Leuven.Inc session 'US and Canadian Medical Devices Regulations'

FDA and CMDCAS regulatory compliance

Medical device companies operate in a complex global regulatory environment with continually changing standards. The medical device market is governed by different national and international standards and regulations. In order to sell products in the US and Canada, companies who manufacture, repackage, relabel and/or import medical devices must prove that the devices they market or sell are safe, effective and meet quality standards. For the US market, they are required to meet the Quality System Regulation 21 CFR 820. For the Canadian market, they need to meet quality criteria based on standards developed by the International Organization for Standardization ISO 13485.

This session gives an overview of the regulations and policies set by the FDA and CMDCAS for the pre-market approval, manufacture and post-marketing compliance of medical devices.  It provides an understanding of the paths to obtain agency approval, the type of controls, systems and documentation they expect to see in place, how they perform inspections and the variety of outcomes. 

Who should attend:

  • QA personnel responsible for the design and implementation of Quality Management Systems
  • Manufacturing & Process Engineers responsible for FDA and CMDCAS compliance 
  • R & D and Design Control personnel required to comply with FDA or CMDCAS QSR
  • Senior Management who need to demonstrate commitment to, and active participation in the Quality System

Practical aspects

Date: Wednesday 14 October 2015
Location: Park-Inn Hotel, Martelarenlaan 36, 3010 Kessel-Lo - Suggestie parking: "Parking Station" (Martelarenlaan)


13h30: Welcome coffee
14h00: Welcome  by Leuven.Inc
14h10: Introduction to FDA compliance practices - Business case
Dirk Loeckx, CEO icoMetrix
14h40: FDA regulations and registration procedure
Jan van Lochem, CEO Qserve Group
  • Introduction to the FDA Organization and current FDA regulatory compliance practices – how to work with FDA investigators
  • Overview of 21 CFR 820 Quality System Regulation for medical devices
  • Registration procedures: 510(k) procedure, PMA, exempt of PMA, De Novo procedure
  •  Classification of medical devices in the US
  • Quality System Requirements (according to 21 CFR 820)
  • Documents and records needed (Design Master Record and Device History File)
16h00: Coffee break
16h20: CMDCAS regulation and registration procedure
Bart Mersseman, Systems & Services Certification Medical Devices SGS
  • Introduction to the Canadian Law SOR98/820
  •  Classification of medical devices in Canada
  • Registration procedures
  • MDL Medical Device License and MDEL Medical Device Establishment License
  •  Essential Safety and Performance requirements according to the Canadian Law
  • Quality System Requirements
17h30: Discussion and Q&A
18h00: Networking

Participation fee

110 euro (excl. VAT): members of Leuven.Inc
150 euro (excl. VAT): all others

Participation in our activities at -50% discount via KMO-portefeuille
Pijler OPLEIDING: Leuven#Inc Approval number DV.O106761
More info:
KMO portefeuille request: for this seminar you indicate 4 training hours


Registrations by Wednesday 7 October at the latest, preferably via the online registration form (use the 'Register' button) or by email to admin@leuveninc.com (including all contact and invoice details).

After registration you will receive a confirmation and route description. The registration fee is payable after receipt of invoice. Cancellation after subscription is not possible. However, replacement by a colleague is allowed.*

* As an (Associate) Company Member you can be replaced by a colleague. As an individual Member you can only be replaced by another Individual Member. When this is not possible, Leuven.Inc will charge an extra fee for the replacement by a non-member.

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