Dr. Gerhard Bauer-Lewerenz
Bauer-Lewerenz Consulting
Referent:innen
Dr. Cornelia Siegl
Marinomed Biotech
Harald Rentschler
mdc medical devices certification
Jesper Wagner
Niras A/S
NEW: ISO 13485/GMP Matrix available for download
Zielgruppe
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.
Zielsetzung
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, especially regarding the new EU Medical Device Regulations.
In the further presentations particular attention will be paid to findings made during FDA inspections. Where possible, there will be links between ISO 13485 and GMP.
Background
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. In May 2021, 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 there are also new (“GMP”-) requirements.
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.
Programm
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 Requirements of EN ISO 13485:2016
- Role of ISO 13485:2016
- Documented procedure
- Key requirements
Technical Documentation vs. DHF/DMR
- Content of Technical 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
- Medical devices versus medicinal products – the key differences
- 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 define a combination product in the EU and US
- Roles of Competent Authorities (CA) and Notified Bodies (NB)
Design Controls
- Introduction of regulatory requirements
- Common aspects/differences regarding the requirements of the ISO 13485 and 21 CFR 820
- New ISO 13485:2016 requirements
- 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
- DSAP Audtiting Organisatons
- 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
Weitere Informationen
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Conference language
The official conference language will be English.
The official conference language will be English.
Fees (per delegate, plus VAT)
ECA Members € 2,090
APIC Members € 2,190
Non-ECA Members € 2,290
EU GMP Inspectorates € 1,145
per delegate plus VAT. The conference fee is payable in advance after receipt of invoice.
ECA Members € 2,090
APIC Members € 2,190
Non-ECA Members € 2,290
EU GMP Inspectorates € 1,145
per delegate plus VAT. The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
All participants will get a link to the Medical Device Warning Letter Navigator. This link will lead you to:
- The Medical Device-associated FDA and GHTF Guidelines with regard to Quality as pdf files
- EU Medical Device-Directives, Regulations and MedDevDocuments
- All Medical Device-associated FDA Warning Letters since 2002
PLUS the document „Essential Requirements Validation of Processes for Production and Service Provision (including Software)” developed by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) – English translation. This 8 pages 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.
For practical assistance: ISO 13485/GMP Matrix available for download
The matrix compares the ISO 13485 requirements with GMP-requirements regarding EU GMP Guideline Part I for medicinal products
The matrix compares the ISO 13485 requirements with GMP-requirements regarding EU GMP Guideline Part I for medicinal products
Contact
Questions regarding Content:
Mr Sven Pommeranz, +49 (0) 62 21 84 44 47, pommeranz@concept-heidelberg.de.
Questions regarding Organisation:
Mr Max Bauer, +49(0) 62 21 84 44 25, bauer@concept-heidelberg.de.
Datum & Uhrzeiten
Tue., 25 November 2025, 09.00 - 16.30 h
Wed., 26 November 2025, 08.30 - 17.15 h
All times mentioned are CET.
Wed., 26 November 2025, 08.30 - 17.15 h
All times mentioned are CET.
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This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
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E-Mail: info@concept-heidelberg.de
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