Integrated GMP for Medical Devices - Live Online Training
ISO 13485 and US QMSR
1/2 December 2026
Course No. 22749
Speakers
Dr. Gerhard Bauer-Lewerenz
Bauer-Lewerenz Consulting
Harald Rentschler
mdc medical devices certification
Jesper Wagner
Niras
Dr. Cornelia Siegl
Marinomed Biotech
- GMP vs ISO 13485 vs US QMSR
- AI Governance in GMP- and ISO 13485 Regulated Environments
- Notified Body Opinion
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
Target Group
This event has been especially designed for the manufacturers who are subject to the medicinal product AND medical device legislation and want to become familiar with the practice-oriented implementation of the legal requirements in the USA and in Europe.
Objectives
he aim of the course is to identify similarities and differences between the regulations for Medicinal Products (GMP) and 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 MDR vs ISO 13485 vs Device History File and Device Master Record • Combination Products • Validation / Qualification in Hybrid Pharma & Medical Devices Environments • Computerized Systems, Data Integrity and Annex 11 in Medical Device Environments • Regulatory/Notified Body Audits • AI Governance in GMP- and ISO 13485 Regulated Environments
A Notified Bodies representative will explain explaining the regulatory requirements, especially also regarding the EU Medical Device Regulations and the GMP-related Requirments of ISO 13485. He also give hints to Regulatory, Notified Body and MDSAP Audits.
In the further presentations particular attention is given to links between ISO 13485 and GMP.
Programme
Overview of similarities and differences between Medicinal Products and Medical Devices
Compare medicinal-product and medical-device regulatory Frameworks
Explain regulatory submissions and market-access pathways
Navigate GMP guidelines, standards and supporting guidance
Contrast supervision, vigilance and post-market oversight.
Certification Procedure under the European MDR
Designation and classification of medical devices
Notified Bodies
Steps in the certification procedure
FDA QMSR: ISO 13485 Alignment and US-Specific Requirements
Explain QSR-to-QMSR changes effective February 2026
Understand ISO 13485 incorporation into FDA regulation.
Identify FDA-specific records, labelling and complaint requirements
Compare FDA, ISO 13485 and European expectations
Prepare for risk-based QMSR inspections and record access
Classification and Premarket Submission of Medical Devices in the USA
Classification rules in the USA
IDE
510k, PMA
De novo, HDE
Q &As
GMP-Related Requirements of EN ISO 13485:2016
History and role of ISO 13485
Comparison of GMP Part I with ISO 13485
Other selected GMR requirement vs. ISO 13485
Technical Documentation vs. MDR vs DHF/DMR
Content of Technical Documentation vs MDR
Technical Documentation as a linking document between production and quality control
Change Management – Retests
How to handle old US DHF and DMR
Audit and inspection findings
Q &As
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)
Qualification and Validation in Hybrid Pharma & Medical Device Environment
Compare FDA, ISO, IMDRF and EU GMP requirements
Apply risk assessments across hybrid manufacturing environments
Plan qualification from URS through DQ, IQ, OQ and PQ
Validate processes and maintain continued process control
Recognise recurring audit and inspection findings
Computerized Systems, Data Integrity and Annex 11 in Medical Device Environments
Define computerised-system expectations within ISO 13485 and QMSR
Apply risk-based validation throughout the system lifecycle
Protect data integrity using ALCOA+ and technical controls
Manage suppliers, access, audit trails, backups and changes
Translate Annex 11 principles into medical-device quality systems
Q &As
Regulatory Audits under MDR and MDSAP
Introduction to MDSAP
Focus point of regulatory audits
Unannounced audits by Notified Bodies
AI Governance in GMP- and ISO 13485 Regulated Environments
Distinguish medical-device AI from supporting quality-system applications
Navigate ISO 13485, QMSR, GMP and AI requirements
Establish roles, oversight and risk-based approval of AI use
Apply lifecycle controls for validation, data and suppliers
Monitor performance, changes, incidents and continued compliance - Current status and availability of AI support - Possible QM use cases - Pitfalls - Adaption to company needs
Q &As
Further Information
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Conference language 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.
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.
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
Testimonials
