PRRC Academy Welcome in the PRRC Academy, the home of the Training Services of Boumans Regulatory Consulting. PRRC announcements New trainings curriculum for 2024 2022, November 26 Our curriculum Our courses PRRC Academy 2024 02-19 & 26 | In-house manufacturer PRRC starter training PRRC Academy 2024 03-05 & 12 | In-house authorized representative PRRC training … Read more
Privacy policy Boumans Regulatory Consulting is responsible for the processing of personal data as reflected in this privacy statement. Stadserf 114, 3112 DX Schiedam NL +31 6 3928 0403 ronald@boumansconsulting.com Chamber of Commerce 86140671 Personal data that we process Boumans Regulatory Consulting processes your personal data because you use our services and/or because you provide … Read more
Your free document Freebie 1 €0 Remove Personal info Email address * We will send the purchase receipt to this address. First name * We will use this to personalize your account experience. Last name * We will use this as well to personalize your account experience. Your organisation* Number of employees Optional Your role … Read more
Our curriculum of regulatory skills trainings is under constant development. Read more about it.
Incorporated IVD A multi-component device is intended to be used surgically invasive, where a specific intervention can be performed via a minimally invasive technique. During this operation, a sample can be taken and stored in a container for transfer to the lab. Sampling is optional, it is not the main objective of this intervention. When … Read more
Do standalone devices exist? Medical devices are typically used in a wider therapeutic or diagnostic context. They are often used together or sequentially with other products, often medical devices or medicinal products, and sometimes also other types of products. They may be connected or compatible, they may interface or be used simultaneously. They may use … Read more
Helping your notified body working efficiently We all know that notified bodies are in short supply and they should work as efficient as possible. There is something we can all do to help: prepare documentation well. It sounds obvious, but I still have to explain to companies that notified body reviewers want to see clear, … Read more
Article 16 inconsistencies As you can read in another tip of the week, MDR Article 16 allows for a third party to repackage or relabel a device or to translate the instructions for use and add them to a device already placed on the market. Packaging, labelling and providing user information are typical manufacturer’s responsibilities … Read more
Manufacturer versus importer/distributor The MDR relates specific roles and responsibilities to manufacturers, importers and distributors. Only the manufacturer should therefore make changes to the information provided with the device and the packaging. However, sometimes the importer and/or the distributor make such changes. Article 16 of the MDR/IVDR sets out when such change puts a manufacturer … Read more
Boumans Regulatory Consulting BV
