GMP for Medical Devices

GMP for Medical Devices

Berlin, Germany

Course No 17190


This conference already took place. To get a list with courses and conferences in a specific subject area according to your professional demands, please visit GMP Training Courses and Conferences by topic.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Dr Gerhard Bauer, Bauer-Lewenz Consulting

Harald Rentschler, mdc, medical devices certification GmbH

Dr Heinrich Prinz, PDM-Consulting


The aim of the course is to identify similarities and differences between the regulations of the FDA and the European regulations for Medical Devices. The focus will be on

  • Classification Rules and Submission in the USA
  • Certification Procedures
  • Technical Documentation vs Device History File and Device Master Record
  • Combination Products
  • Design Controls
  • Validation / Qualification
  • Regulatory Audits
  • CAPA and Complaint Handling
A Notified Bodies representative will start the course by explaining the regulatory requirements. In the further presentations particular attention will be paid to findings made during FDA inspections.

3 Parallel Workshops
concentrating on technical documentation, classification and submission and audit findings, will provide practical orientation:

How to structure a technical documentation

Classification and Submission of Medical Devices in the USA
How to classify and submit Medical Devices in the USA?

Preparing for an Audit According to the New European MDR
For two examples of medical devices relevant sections of the new European MDR will be analysed in order to identify the main audit items, which contain new or enhanced requirements.


Since 1996, the requirements for the development, the manufacture and the distribution of medical devices in the USA have been laid down in the revised cGMP regulations for Medical Devices (21 CFR 820, QSR). In the USA, medical devices are regulated by the FDA’s Center for Devices and Radiological Health (CDRH). Inspections are primarily performed by the FDA.

In Europe, three EU directives (90/385/EWG, 93/42/EWG and 98/79/EG) and one amending directives regulate the medical devices industry. Soon the new Medical Device Regulation will come into force. GMP regulations - strictly speaking - are not notified. Instead, harmonised standards, especially ISO 13485, represent the state-of-the-art in the area of the EU. Inspections are primarily performed by Notified Bodies („New Approach for Product Regulations and Conformity Assessment“).

With the revision of the ISO 13485 in 2016 also new (“GMP”) requirements will come.

Statistical data about deficiencies of medical devices do only exist in the USA because of the Freedom of Information Act. For years now, CAPA/Complaint Handling, insufficient Design Controls, Management Responsibility, Process Controls and Process Validation and Quality Audits have been among the Top 10 deviations.

Target Group

This event has been especially designed for the manufacturers who are subject to the medical device legislation and want to become familiar with the practice-oriented implementation of the legal requirements in the USA and in Europe.

Three add-ons for free

FDA Medical Device Warning Letter Navigator on USB Stick
This stick contains:
The Medical Device-associated FDA and GHTF Guidelines with regard to Quality as pdf files
EU Medical Device-Directives and MedDev Documents
All Medical Device-associated FDA Warning Letters since 2002.

You will also receive the document „Validation of Processes for Production and Service Provision (including Software) - Essential Requirements” developed by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) – English translation. This 8 page document aims at reaching a common understanding of validation of processes, including validation of software among notified bodies, manufacturers and the competent authorities, and at defining uniform requirements on the validation of processes to be met by the manufacturers and on the auditing of these processes by notified bodies or certification authorities.

Change Control SOP:
All delegates receive an example of a Change Control SOP with a Change Control Flowchart and a Change Application Form.


Overview about similarities/differences between

  • Medicinal Products and Medical Devices
  • Regulatory Submission
  • Guidelines
  • Supervision
Certification Procedure under the European MDR
  • Economic Operators
  • Classification of medical devices
  • Selection of certification procedure
  • Certification by Notified Bodies
Differences between EU and FDA Requirements
  • European Requirements
  • FDA Requirements
  • Differences and common interests
Classification and Premarket Submission of Medical Devices in the USA
  • Classification rules in the USA
  • IDE
  • 510k, PMA
  • De novo, HDE
    • GMP-Related Requirments of EN ISO 13485:2016
      • Role of ISO 13485:2016
      • Documented procedure
      • Key requirements
      Technical Documentation vs. DHF/DMR
      • Content of Technical of Documentation
      • Technical Documentation as a linking document between production and quality control
      • Change Management – Retests
      • Content of the DHF
      • Relation to the DMR
      • Link to Technical Documentation
      • Audit and inspection findings
      Combination Products
      • The Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products – an overview
      • Combination products in the EU – Guidelines and Definitions
      • How to classify the combination product
      • Conformity assessment
      • The consultation procedure
      Design Controls
      • Introduction of regulatory requirements
      • Common aspects/differences regarding the requirements of the ISO 13485 and 21 CFR 820
      How to implement Design Controls in the whole life cycle process
      • Modern concepts of development of products
      • Audit and inspection findings
      Qualification and Validation
      • Regulatory requirements (FDA, Standards, GHTF)
      • Risk assessments
      • Qualification
      • Validation
      • Audit and inspection findings
      Regulatory Audits under MDR and MDSAP
      • Purpose of the MDSAP
      • MDSAP Audtiting Organizatons
      • Focus point on regulatory audits
      • Unannounced audits by Notified Bodies
      CAPA/Complaint Handling
      • Regulatory requirements (EU, FDA, Standards, GHTF)
      • Common aspects/differences regarding the requirements of the ISO 13485 and 21 CFR 820
      • New ISO 13485:2016 requirements
      • CAPA – the motor for continuous improvement
      • Monitoring as a subsystem
      • Interface complaint handling /CAPA System
      • Audit and inspection findings

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