Dr. Gerhard Bauer-Lewerenz
Bauer-Lewerenz Consulting
Referierende
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
Zielgruppe
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.
Zielsetzung
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.
Programm
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
Weitere Informationen
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.
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.
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 6221 84 44-47, pommeranz@concept-heidelberg.de
Questions regarding Organisation:
Ms Jessica Frechen +49 6221 84 44-60, frechen@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 1 December 2026, 09:00 -16:30 h
Wed, 2 December 2026, 08:30-16:45 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 2090,- |
| Non ECA Member*: | € 2290,- |
| EU/GMP Inspectorates*: | € 1145,- |
| APIC Member Discount*: | € 2190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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