Dr. Gerhard Bauer-Lewerenz
Bauer-Lewerenz Consulting
Referent:innen
Dr. Heinrich Prinz
PDM Consulting
Harald Rentschler
mdc medical devices certification
Jesper Wagner
Niras A/S
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.
Hintergrund
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.
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.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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
- 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
- DSAP 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
Recording from 21/22 November 2023
Duration of the recording: approx. 9 h 38 min.
Duration of the recording: approx. 9 h 38 min.
| ECA-Member*: | € 1690,- |
| Regular Fee*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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