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:
Date: Wednesday 14 October 2015
Location: Park-Inn Hotel, Martelarenlaan 36, 3010 Kessel-Lo - Suggestie parking: "Parking Station" (Martelarenlaan)
|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
|16h20:||CMDCAS regulation and registration procedure
Bart Mersseman, Systems & Services Certification Medical Devices SGS
|17h30:||Discussion and Q&A|
|110 euro (excl. VAT): members of Leuven.Inc
150 euro (excl. VAT): all others
Participation in our activities at -50% discount via KMO-portefeuille
Registrations by Wednesday 7 October at the latest, preferably via the online registration form (use the 'Register' button) or by email to firstname.lastname@example.org (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.