Regulatory Affairs
Qserve Consultancy in co-operation with Qserve America offers a wide array of training courses in respect to regulatory affairs and statutory requirements in the medical device industry. Qserve delivers these courses in English or Dutch, at Qserve offices, external locations and on-site at your own organization both in the EU and the US.
Regulatory requirements in the following jurisdictions are covered:
Europe
the European Medical Device Directives, including
AIMD, Active Implantable Medical Device Directive (90/385/EEC)
MDD, Medical Device Directive (93/42/EEC)
IVD, In Vitro Diagnostic Medical Device Directive (98/79/EC)
US
the FDA regulatory compliance requirements, including
510k, Pre Market Notification
IDE, Investigational Device Exemption
PMA, Pre Market Approval
21 CFR Part 820 of the Food Drug and Cosmetics Act, Quality Systems Regulations (QSR) for Medical Devices
Canada
the Canadian Medical Device Regulations (CMDR) and the Canadian Medical Devices Conformity Assessment System (CMDCAS)
Australia
regulatory requirements for Medical Devices prescribed by the Therapeutic Goods Administration (TGA). Therapeutic Goods (Medical Devices) Regulations, 2002, and Therapeutic Goods Amendment (Medical Devices) Act, 2002.
New Zealand
regulatory requirements for Medical Devices prescribed by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe); New Zealand utilizes the Australian medical device regulations.
Topics include:
Introductory course/workshop "Medical Device Directive a Better Understanding" (half a day)
Course "Medical Device Directive Compliance" with exam (2 days)
"CE Marking of Medical Devices Conform the European Medical Device Directive(s)"
- Device classification
- Conformity route assessment
- Compiling a Technical File and Design Dossier (half a day)
- Pre-clinical Testing, Clinical, Shelf life, Labeling, Packaging and Sterilization
- Validations
- Design and risk analysis
- Implementation of Complaint, Recall, and Vigilance systems
- Post Market Surveillance (PMS) system
- FDA/QSR requirements "FDA Regulatory Compliance Requirements"
- CMDR, Canadian Medical Device Regulations, CMDCAS requirements "CMDR & CMDCAS"
- Requirements for Australia and New Zealand
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Course code RA1
Introductory course/workshop "Medical Device Directive a Better Understanding" (half a day)
Course description:
This course/workshop is intended to provide a basic introduction to one of the Medical Device Directive(s), the AIMD, MDD or IVD, as per your requirements. It systematically examines Medical Device Directives in the EU and the “New Approach”. Global Harmonization as related to the Medical Device Directives is discussed. The specified Directive is considered in more detail including: the Definition of a Medical Device; the Roles of the Notified Body and Competent Authorities; the Classification Rules and Criteria; the Conformity Assessment Route; Quality Management System requirements; Post Marketing Surveillance and Vigilance requirements; Technical Documentation; Standards and Essential Requirements; Labeling; and Clinical Data.
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Course code RA2
Course " Medical Device Directive Compliance" with exam (2 days)
Course description:
This two-day comprehensive course provides participants with an in-depth understanding of the requirements of the EU Medical Device Directives and the CE Marking approach and focuses on the Medical Devices Directive (MDD) including active and non-active medical devices. It gives participants the latest information regarding the interpretation and enforcement of these Directives. Most importantly, it facilitates your company to put medical devices on the EU market (25 countries and still expanding) more quickly!
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Course code RA3
Techical file (half a day)
Course description:
This course is intended to provide a basic overview of making a technical file for conformity assessment for medical devices.
For the Benelux, the course is provided in co-operation with the "NEN-Cursussen", the Dutch Standardization Institute. It is normally conducted in Dutch. If preferred, it can be given in English.
(This course must be booked through the NEN website)
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Course code RA4
FDA Regulatory Compliance Requirements
The content of this course is currently under review and will be posted shortly.
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Course code RA5
CMDR & CMDCAS, Canadian Medical Device Regulations & Canadian Medical Devices Conformity Assessment System (half a day)
Course description:
This short course covers the specific regulatory requirements of the Canadian MDR, which any medical device manufacturer wishing to export to Canada must be in a position to fulfill. The Canadian “Medical Device Regulation” act of 1998 is reviewed in detail and its relationship to the EU MDD and FDA/QSR is discussed. Since January 1 st 2003, the Canadian Medical Devices Conformity Assessment System (CMDCAS) requires the mandatory audit of the medical device manufacturer’s Quality Management System against ISO 13485 in the context of the CMDR; this feature is explained. Participants will be provided with a list of organizations, which are currently accredited to audit EU medical device manufacturers according to CMDCAS.
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Qserve also offers training in any of the above focusing on a specific regulatory element, e.g., “Implementation of complaint, recall and vigilance systems”, these courses/workshops can be customized to meet your companies needs.
For more information, please complete the info request form in the "Contact Us" section.