fda requirements for suppliers - process vision

FDA

requirements

for suppliers

Willem van den Biggelaar

Quality & Regulatory Consultant

PROCESS VISION DOWN TO EARTH QUALITY SERVICES

2 of 73 © Process Vision – FDA requirements for suppliers

Let op

• Deze sheets geven alleen maar een summiere indruk

• Nadruk op verschil met ISO 13485

• Nadruk op design, engineering en manufacturing

• Zoals altijd: “The devil is in the details”

• De sheets zijn deels engels, deels nederlands


Content

• Wie is de FDA

• 21 CFR 820 Quality System

• Design controls

• Production and process controls

• Document and record control

• Process Validation

• Training

• CAPA

• Complaint files

• Tenslotte


WIE IS DE FDA


Wie is de FDA

• De Amerikaanse overheidsinstantie FDA controleert en reguleert de volgende producten • Cosmetica

• Voeding

• Medicijnen

• Medische apparatuur

• Producten voor dieren.

• Zij mogen • Produkten weren van de Amerikaanse markt

• Fabrieken stilleggen (in Nederland via Voedsel en Waren authoriteit)

• Boetes opleggen

• Juridisch vervolgen


FDA historie

• Opgericht in 1906 • Aanleiding: slechte hygiëne en wantoestanden in

vleeswerkende industrie in Chicago en omgeving

• 1938 Food, Drug & Cosmetic act • Aanleiding: Sulfanilamide in poedervorm of tabletten werd

gebruikt voor de streptococcus infecties.

• In 1937 bracht een fabrikant dit product zonder te testen in vloeibare vorm op de markt door het op te lossen in diëthyleen glycol (ook wel antivries): 107 mensen (meest kinderen) overleden


Belangrijkste regelgeving

• Code of Federal Regulations (CFR) 21 Food and Drugs • Part 1-99 : Algemene regels

• Part 100-199 : Voeding en additieven

• Part 200-299 : Humane medicijnen

• Part 300-499 : OTC medicijnen en antibiotica

• Part 500-599 : Dier voeding en medicijnen

• Part 600-799 : Biologische en bloed producten

• Part 800-899 : Medische (diagnose) apparatuur • 801: Labeling

• 803 Medical Device Reporting

• 807 Registration and listing

• 831 Medical Device Tracking

• 820: Quality System Regulation (QSR)

• 1997: aanvullende wetgeving voor opslaan van elektronische data en

gebruik van elektronische handtekeningen: • 21 CFR Part 11: Electronic records, Electronic signatures.

• Electronic record is bv test data (ook als je die uitprint en archiveert), je vertrouwt op / werkt met de elektronische versie niet de papieren

8 of 73 © Process Vision – FDA requirements for suppliers 8

US safety and effectiveness

no SADEs *

EU

safety and performance

no SADEs*

* Serious Adverse Device Effect

Regulatory Framework

Market access

what’s in the manual?

what’s in it for the patient?

Yet, you may need effectiveness

data to be able to sell the device


Verschil tussen FDA en ISO 13485

• Compliancy • FDA is verplicht (wetgeving) als je op Amerikaanse markt wilt

• ISO 13485 is vrijwillig, voor Europa is MDD verplicht

• Certificering • ISO 13485 is mogelijk

• FDA is niet mogelijk

• Product labeling • CE label op product verplicht

• Geen FDA label op product wel registratie

• Auditing • ISO 13485 Notified Body audits

• FDA inspectors


Verschil Inspecties CE/ISO13485 - FDA

2011-Marc-03

EU – Notified Body

1. Vertrouwen

2. Openhartig

3. Vooraf vastgestelde agenda

4. Vast aantal audit dagen

5. Auditor geeft belang en consequenties aan

6. Auditor neemt beslissing over non-conformity

7. Vooraf ingepland

8. Betaald door de klant

US – FDA

1. Wantrouwen (guilty unless proved otherwise)

2. Gesloten

3. Agenda niet bekend, spit door

4. Aantal dagen mag verlengd

5. Auditor doet waarnemingen en rapporteert

6. Beslissingen worden door functionaris bij FDA genomen

7. Onaangekondigd (in Amerika)

8. Overheidsinstantie


Wanneer komt de FDA?

• Zij komen in 1e instantie altijd bij de zgn. “legal manufacturers(*)” = degene die product op de Amerikaans markt brengt.

• Zij kondigen minimaal 3 maanden vooraf (in Europa) hun komst aan bij de legal manufacturer

• Zij moeten minimaal 1 x in de 2 jaar een inspectie uitvoeren bij een klasse II of klasse III medical device.

(*) Term “legal manufacturer” kent de FDA niet, CE wel Legal entity that is the final approval authority on design changes and assumes Quality Systems responsibility for the development, design and manufacture of the product .

The Legal Manufacturer may perform all of the activities required to develop, design, manufacture, package, sterilize and place a product on the market OR the legal manufacturer may contract (or by letter of appointment) all or any of these activities to a third party.


QSIT (Quality System Inspection Technique)

• Guideline for the FDA inspectors • http://www.fda.gov/ICECI/Inspections/InspectionGuides/uc

m074883.htm


Device Classificatie volgens FDA Controls Kenmerken Eisen Voorbeelden

I = General Controls

Laag risico Establishment registration Medical Device listing Labeling 21 CFR 820 Quality System

Chirugische handinstrumenten Handschoenen

II = Special Controls

Modaal risico Pre market notification (510k) Performance standards Post market surveillance + General Controls

Infuus pomp Aangedreven rolstoel

III Hoog risico Pre market approval (PMA) iso 510k + Special Controls

Pacemaker Device met nieuwe technologie

• Indien er predicate device (al een goedgekeurd device met gelijke intended use) is te vinden dan 510k route = bewijs dat device al veilig en effectief is

• Bij wijziging van bestaand product ook 510k indien veiligheid en/of effectiviteit niet wordt beinvloed


Plan for 510k clearance (red=also for supplier) 1. Define intended use, indication for use / markets / claims

2. Define strategy on components of the system: seperate FDA routes or combined? Criteria: seperate sale? Future significant changes in one or more components?

3. Define classification (I, II, IIII) conform FDA CDRH database (FDA determines in the end) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm

4. Conformity assessment route depends on chosen classification (I=general controls, II=+510k, III=+PMA) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm

5. Predicate devices 510k database http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

6. Check if “Accredits persons” may perform 510k review (see CDRH database)

7. Check if “Recognized Consensus Standards” from CDHR database are applicable

8. Select harmonized standards (Design input)

9. Implement QMS that complies with 21 CFR820

10. Plan development & regulatory strategy (including a V&V plan)

11. Appoint US Agent: regulatory representative to FDA located in USA

12. Device Registration and Listing (yearly approx. $ 3000 ) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm

13. Comply with medical device requirements (e.g. standards, 510k requirement, labeling )

14. Submit 510k and pay fee (standard $5.000, small business $2500)

15. FDA reviews and issues 510k clearance letter on website

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm


21 CFR 820 QUALITY SYSTEM


7 Key processen in kwaliteitssysteem + 3 regulatory topics (only for legal manufacturers)

Inspectors Focus


Inhoud 21 CFR 820 in subparts

A. General provision scope,

definitions

B. Quality System Requirements Mngmt resp,

policy, audits, personell

C. Design Controls

D. Document Controls

E. Purchasing Controls

F. Identification and traceability

G. Production and process controls

H. Acceptance activities

I. Non conforming products

J. CAPA

K. Labeling and packaging controls

L. Handling, Storage, distribution and installation

M. Records

N. Servicing

O. Statistical Techniques


820.20(d) Quality Plan (niet voor ISO 13485)

• Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.

• A quality plan shows how the Quality System requirements are applied to a device or device type to ensure that it meets specifications and quality requirements. The purpose of a quality plan is to communicate the requirements and controls necessary to manufacture, test, and release devices that meet customer needs. The quality plan covers all quality practices, resources, and activities at all stages of manufacturing, including design, procurement, production, and—when applicable—installation and service.

• Kan apart document zijn of referentie naar DMR • Ref DMR, dan aangeven in Quality Manual hoe de DMR

820.20(d) eis afdekt


DESIGN CONTROLS


820.30 Design controls

Labeling and packaging is also part of design, so must be conform 820.30


820.30 (c) Design Input • Ensure requirements are appropriate and address

intended use of device.

• Address incomplete, ambiguous, or conflicting requirements.

• Document, review, and approve input requirements


820.30 (d) Design Output

• Define and document design output in terms that allow evaluation to design input (measurable)

• Reference acceptance criteria (pass/fail)

• Identify design outputs essential for the proper functioning of device.

• Document, review, and approve design outputs before release.

• Results of design effort at each phase and the end of the total design effort.

• Finished design output is basis for the DMR


820.30 (e) Design Reviews

• A documented, comprehensive, systematic examination to • Evaluate adequacy of the design requirements

• Evaluate capability of the design to meet requirements

• Identify problems

• Ensure that formal reviews of design results are planned and conducted at appropriate stages.

• Ensure participants include representatives of all functions concerned with design stage being reviewed.

• Document results in the Design History File (DHF).


820.30 (f) Design Verification

• Verify the device design.

• Confirm that design output meets design input requirements.

• Document results in the DHF


820.30 (g) Design validation

• Establishing by objective evidence that device specifications conform with user needs and intended use(s).

• Perform under defined operating conditions on initial production units or equivalent.

• Perform process validation in parallel

• Ensure devices conform to defined user needs and intended uses.

• Test of production units under actual or simulated use conditions.

• Perform software validation and risk analysis, where appropriate.

• Document results in the DHF


820.30 (h) Design Transfer

• Ensure the device design is correctly translated into production specifications


820.30 (i) Design Changes • Identify, document, validate or verify, review, and

approve design changes before implementation.


Examples Recognized International Standards

• IEC 60601-1 Basic safety + essential performance

• IEC 60601-1-2 Electromagnetic compatibility

• IEC 60601-1-8 Alarm systems

• IEC 62304 Software life cycle processes

• IEC 62366 Usability engineering

• ISO 14971 Risk management

See http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm


Risk Management cyclus (ISO 14971) Throughout the life time of the device! Be sure to agree with the legal manufacturer who does what.


Strenge document control op docs/records

• Consistentie door alle specs, reports, etcera heen • Project namen

• Product namen

• Definities en afkortingen

• Handtekening(en) voor review en goedkeur • Ook na goedkeur bij aanpassingen

• Volgorde goedkeur van belang • Bv test report na test spec, design na requirements

• Werk altijd met approved input documenten • Tussendoor approval is geen probleem

• Correcte document identificatie en versiebeheer (terugvindbaarheid)

• Requirements en test traceability (zie volgende sheet)


Requirements and test traceability example

Product Validation

Report

System

Verification Report

Detailed Verification

Report

User Needs

Intended Uses Regulatory

standards

System Requirements

Detailed Requirements

Implementation

(Integration) Test

ReportSystem Design

1

2

5

6

7

Detailed Design

3

4

Sa

fety

/ S

ec

uri

ty R

isk

Ma

na

ge

me

nt

File

9

8


Example design process

Defintion and

Quotation

phaseFEN-PCP01

Concept phaseFEN-PCP02

Design phaseFEN-PCP03

Proto phaseFEN-PCP04

Pilot phaseFEN-PCP05

Series phaseFEN-PCP06

Go Go Go Go Go

CustomerProject Request

Quotation

PO

Require-

mentsQuote

PODesign

Review

Request

Design

Approval

Series Products

Pilot Products

Material flow

Product Safety

Risk

ManagementFEN-PCP13

Product/

Process FMEAFEN-PCP12

Customer TPD

projectFMT-PCP11

Customer

TPD

Customer

Request

for product

Pilot /

Series

Products

Product Creation Process (PCP)

Information flow

Setup Assembly

Process FMT-PCP30

QA / PE in PCP

CM

Glovia

PRP

Glovia

EGMS = Engineering Maintenance Screen

CM = Contract Management

PRP = Project Resource Planning

Project

Leader

Validated

Tools

Safety

risks

Control

Measures

Control

Measures

MSAFEN-PCP16

MSA

needed

MSA

Report

Tool ValidationFEBV-ICT05

TPDAssembly

Binder

Setup Product

Labeling FMT-PCP33

Process

Validation FMT-PCP32


PRODUCTION & PROCESS CONTROLS


820.70 (a) Production and process control

• Develop, conduct, control and monitor production processes in order to • Ensure device is conform specifications (defined and approved

during design)

• To prevent non conformance, process controls are to be defined:

• Procedures and standards

• Workmanship

• Manufacturing instructions

• Process validation

• Inspection, testing

• Process Monitoring (e.g. SPC)

• ………..


820.70 (b) Production and process changes

• Elke verandering in productie proces of product moet • Volgens een procedure lopen

• Gechecked op regulatory impact

• Geverifieerd of gevalideerd indien nodig (820.75)

• Gedocumenteerd volgens doc control (820.40)

• Approved

• Voorbeelden: nieuw product, (interne) verhuizing

• Het beste is als er 1 change proces is voor zowel development en productie


820.70 (c) Environmental Control

• Degree of environmental control must be consistent with the intended use of the finished device. • Lighting, ventilation, temperature, humidity, air, pressure,

air flow, filtration, airborne contamination, microbial contamination, electrostatic discharge (ESD)

• Requirements for environmental controls must be defined and documented (during design phase)

• Procedures required to ensure control of conditions (monitoring) and periodic inspection (audit) of the control systems.


820.70(d) Personnel • Define requirements and establish procedures when

unclean employees, inappropriately dressed employees, or employees with medical conditions could adversely affect the quality of the product.

• Hygiene requirements such as hand washing practice

• Storage of food and drink in work areas

• Dress codes and cleanliness


820.70(e) Contamination Control • Establish and maintain procedures to prevent

contamination of equipment, components, manufacturing materials, in-process devices, finished devices, and returned devices by substances that could adversely affect device safety or effectiveness.

• There must be periodic, documented checks or inspections to verify that the contamination control system is properly functioning.

• Examples pest control, hazardous substances


820.70(f) Buildings • Buildings shall be of suitable design and contain

sufficient space to perform necessary operations, prevent mixups, and assure orderly handling.

• Floor plan: flow of product and designates: • receiving areas;

• areas for acceptable and rejected products;

• manufacturing areas;

• storage areas for components and finished goods;

• rework, reprocessing, and repair areas;

• office space; and

• non-manufacturing areas (e.g., cafeterias and restrooms).


820.70(g) Equipment • Ensure that all equipment (e.g., fabrication, molding,

extrusion, assembly, packaging, and sterilization equipment) is appropriately designed and installed to facilitate maintenance, adjustment, cleaning and use.

• Equipment must also meet requirements (made during

design phase) that ensure its proper functioning in the manufacture of the device.

• Provide maintenance procedure, schedule and records

• Some adjustments (defined in DMR or a procedure) are allowed by operator


820.70(h) Manufacturing Material • Establish procedures for the use and removal of any

manufacturing material and document the removal or reduction of the material (in DHR)

• Examples: cleaning agents, mold-release agents, lubricating oils, latex proteins, sterilant residues

• Only when the manufacturing material could potentially have an adverse effect on product.

• The requirement also applies to processing, reprocessing, repair, and rework.

• Define for third parties allowable manufacturing materials


820.70(i) Automated Processes • All software used in production or in the Quality

System, whether for design, manufacture, distribution, or traceability, is validated for its intended use.


Example manufacturing process

CleanroomFM-MAP52

ProductionFMT-MAP06

Order PickingFMT-MAP05

Incoming

Inspection

Critical Comp.FMT-MAP04

Release for

ProductionFMT-MAP01

Goods ReceiptFMT-MAP02

ShippingFMT-MAP07

Calibration

EquipmentFMT-MAP09

Work Order

Planning

Pick

list

Work Order

with picked material

Packed

device

Shipped

Device

Material

Purchased items

Non critical

Components

QA status 3

Critical

Components

QA status 1

Approved

Critical

Components

Calibrated

Equipment

Calibraiton

Reports

Device

DHR

LOG

Stock

NC

received

Component

NC

Received

Component

NC

Product before

End test

Non

Conforming

Internal GoodsFMT-MAP10

8D

Scrap

Retour / Repair

to supplier

LOG

Material

On the floor

Returned

Goods

Customer Material

Material flow

CleaningFMT-MAP51

Material

Cleaned

Material

LOG

LOG

Manufacturing Process (MAP)

Logistics (LOG)

QA / PE in Manufacturing (MAP)

Information flow

ESDFMT-MAP50

Use

As is

Stock

DHR = Device History Reocrd

DMR = Device Master Record

NC = Non Conforming

Quality

Managment

Glovia

DMR

Teamcentre

Stock

Supplier

Non

Conforming

ProductsFMT-MAP14

NC

Product after

End test

8D

Customer

Approve

Deliver

with DN or Rework


DOCUMENT & RECORD CONTROL


Documentatie: DHF/DHR/DMR

product docs

Order

confirmed

End of

production

Start Design

Phase

Design &

Engineering

Production

EngineeringSales Production

Customer

(Service)

product docs order data service data

DHF index

Design

History

File

(DHF)

DMR index

Device

Master

Record

(DMR=TPD)

DHR Index

Device

History

Record

(DHR)

Device

History

Record

(DHR)

As

delivered

DHR Index

Device

History

Record

(DHR)

End of

Service

Start Series

Phase

Start Proto

Phase

Design

Transfer

production data

Supplier responsibility Customer responsibility

Abbr. Record Type Description

DHF 820.30 (j)

Design History

File

Compilation of records which described the design history of a finished device. There is a history file per

designed device.

It provides proof that product is designed according project plan.

E.g. System Requirements, System Design, test specifications, test reports, project plan.

DMR

(TPD)

820.81

Device Master

Record

Compilation of records containing procedures and specifications for a finished device. There is a master record

per designed device.

This information needed by manufacturing, end users and service.

E.g. assembly instructions, instructions for use, service manual,

DHR 820.184

Device History

Record

Compilation of records containing the production history of a finished device. There is a history record per

produced device (particular unit or batch of devices). It is the order, production and service history of a device

E.g. confirmed sales order, acceptance records (to DMR) and calibration records.


DHF/DMR/DHR: traceability

• Van elke geproduceerde DHR moet traceerbaar terug te vinden zijn op welke DMR deze gebaseerd is

• Van elke gebruikte DMR moet traceerbaar terug te vinden zijn op welke DHF deze gebaseerd is

Design

History

File

(DHF)

Device

Master

Record

(DMR)

Device

History

Record

(DHR)


820.184 Inhoud DHR • Aantal geproduceerd inclusief productie datum

• Aantal gedistribueerd

• SN# systeem

• BOM inclusief eventuele SN# van componenten

• Referentie naar gebruikte DMR (Doc Id’s + versies)

• Gebruikte (gecalibreerde) meetapparatuur

• Gebruikte labels (identificatie)

• Identificatie + software versies test programmatuur

• Meetresultaten

• 820.80 Acceptatie resultaten/conclusie/review/approval

• 820.90 Non conforming records


En nog wat records

• Alle procedures (820.186 Quality System Record)

• Alle niet device gerelateerde records • Voorbeelden

• 820.20 (c) Management review records

• 820.22 Audit records

• 820.25 Training records

• 820.72 Calibration records

• 820.100 CAPA records

• 820.198 Complaint records

• Zijn ook allemaal terug te vinden binnen ISO 13485


Good Documentation Practices (GDP) • Gebruik permanente blauwe inkt

• Eenduidige datum notatie: bv JJJJ-MMM-DD

• Eenduidige naam notaitie: bv initialen + achternaam

• Leesbaar, bv in blokletters

• Geen lege cellen, NA alleen als is toegestaan

• Correcties? Doorhalen met enkele lijn, naam + handtekening + datum + reden

• Gebruik geen “aanhangsels” zonder identificatie

• Afronden getallen alleen bij uitkomst, niet bij bewerking

• Handtekening = verklaring dat je iets hebt gedaan, reden moet helder zijn voor de persoon die tekent

• Handtekening bij afwezigheid alleen door bevoegde personen

• Maak goede templates en train de mensen op GDP


Template voorbeeld - 1


Template voorbeeld - 2


Digitale handtekeningen? CFR 11

ELECTRONIC RECORDS AND ELECTRONIC SIGNATURES

• Part 11 will not apply when: • computers are used to generate paper printouts of

electronic records and

• these paper records meet all predicate rule requirements and

• persons rely on the paper records to perform regulated activities.


PROCESS VALIDATIE


820.75 Process Validatie

• 820.3(z)(1) Process validation • Establishing by objective evidence that a process

consistently produces a result or product meeting its predetermined specifications.

Different from design validation

• 820.3(z)(2) Design Validation • Establishing by objective evidence that device specifications

conform with user needs and intended use(s).


Typical Process Validation examples

• Solderen

• Schoonmaken

• Lijmen

• Sterilisatie

• Spuitgieten

• Sealen

• Lassen

• Software controlled systemen

• Vertinnen

• Vriesdrogen

• Warmtebehandeling

If requirements of

product can only be

assured by destructive

testing then validation

is needed


Software tool validatie niet alleen in productie zoals bij ISO 13485

• Maar ook in development & engineering : • Compilers / linkers

• CAD/CAM systemen

• Calculaties

• DHF/DMR archiving/versioning systems

• …....

• En op het kwaliteitssyteem: • CAPA database

• QMS Change request tool

• Customer complaint database

• QMS procedure version / archive tool

• Performance Indicator generation (Metric/KPI)

• ……..


Software validation approach


TRAINING


Personell

• Hire sufficient personnel with necessary education, background, training, and experience.

• Make personnel aware of device defects that could occur from improper job performance.

• Make personnel aware of defects and errors that could be encountered as part of their job.

• Establish procedures for identifying training needs and to ensure personnel are adequately trained.


Training

• Kwaliteits systeem: functies/rollen

• Functie omschrijving: taken en verantwoordelijkheden

• Organigram: wie heeft welke functie

• Skills matrix: wie heeft welke taken + training status

• Training records: wie is getrained op welke taak

• Bovenstaand “bouwwerk” moet consistent en compleet zijn


CAPA


CAPA afhandeling

5.1 Measure and 5.2 Analyse

coordination / linkage of data / data sources / “horizontal analysis”

5.0 Phase II

Measurement and

Analysis within and

across Data Sources

6.0 Phase III

Improvement

4.0 Phase I

Planning4.1 Plan for Measurement, Analysis and Improvement Processes

7.0 Phase IV

Input to Management7.1 Report to Management and 7.2 Management Review

Examples of defined Data Sources

Within each data source

4.2 Establish Data Sources and Criteria

Fe

ed

ba

ck

Co

mp

lain

ts

Se

rvic

e R

ep

ort

s

Sp

are

pa

rts u

sa

ge

Qu

alit

y A

ud

its

(in

tern

al / e

xte

rna

l)

Su

pp

lier

Pe

rfo

rma

nce/C

on

tro

ls

Pro

ce

ss C

on

tro

ls

Re

turn

ed

Pro

du

ct

Ma

rke

t / cu

sto

me

r

su

rve

y

Improvement

6.1 Investigate 6.2 Identify Root Cause

6.3 Identify Actions

6.4 Verify

identified Actions6.5 Implement Actions

6.6 Determine

Effectiveness of

Implemented Actions

Source: GHTF/SG3/N18:2010


CAPA geintegreerd met risk management Source: GHTF/SG3/N15R8


COMPLAINT FILES


820.198 Complaint Files (also FDA focus) • Be sure to involve all disciplines necessary:

• Clinical expert, compliance expert, marketing, …….

• Be sure that root cause is effectively solved (via CAPA)

• Establish and maintain procedures for receiving, reviewing, and evaluating complaints.

• Procedure must ensure that • Oral complaints are documented upon receipt.

• All complaints processed uniform and timely.

• Complaints evaluated to determine whether complaint represents a Medical Device Report (adverse event).

• Review and evaluate all complaints if investigation is necessary.

• Records of investigation are maintained

• No investigation? Justification + name individual responsible for the decision.


And the other sub systems briefly explained



To provide adequate resources for operations. To monitor the quality system, make necessary

adjustments, and assure the quality system is functioning properly

Management Review, Management Representative

Quality Policy, Quality System procedures, Audits, Training



To assure that all products that are accepted, used, and distributed meet specifications

“Products” includes components, manufacturing materials, in-process devices, finished devices,

and returned devices

Purchase,

statistical techniques,

incoming, in-process, final acceptance,

identification & traceability,

labeling, packaging, handling,

storage, distribution

Non conforming products



To assure:

Specifications and procedures are adequate

Only current documents are used

Changes are reviewed, approved and incorporated into documents

Documents are maintained for the required length of time

Device Master Record (DMR),

Device History Record (DHR),

Document control

Quality System Records (QSR)



To assure that devices are not adversely affected by the manufacturing environment, buildings or

equipment Provide adequate resources for operations

Buildings,

equipment control,

environment control (eg ESD, cleanroom)


TENSLOTTE


FDA references

Home page http://www.fda.gov/MedicalDevices/default.htm

A-Z http://www.fda.gov/SiteIndex/default.htm

510k database search http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

Product code database http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

Recognised standards http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

CFR 21

Device Registration

and Listing

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYour

Device/RegistrationandListing/default.htm

Training Overview http://www.fda.gov/Training/CDRHLearn/ucm162015.htm

Training QSR 820 http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm

http://www.fda.gov/MedicalDevices/default.htm

http://www.fda.gov/SiteIndex/default.htm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm





http://www.fda.gov/Training/CDRHLearn/ucm162015.htm



http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm


How to continue.......

• Perform FDA Gap analysis on current Quality Management System (QMS)

• Implement gap analysis in QMS

• Pick a pilot project to validate the QMS changes

• Implement the project with QMS changes

• Evaluate