What is a regulatory strategy
How do I select the country where I want to sell my devices?
How do I find the information I need to sell my devices?
How do I register medical devices in the world
Marketing in Canada: what is the difference between MDAL and MDEL?
Marketing in Brazil: do I need to get the INMETRO mark?
What is the 510(k)?
Marketing in China: what is the Legal Agent responsible for?
Why is the CE marking required
When is the Notified Body’s intervention needed?
How will the IVDR 2017/746 affect the Quality System Management?
How can I establish a medical device risk class ?
What is the OBL contract?
When do I have to appoint an Authorized Representative?
When will the IVDR 2017/746 enter into force?
What does the entry into force of IVDR 2017/746 entail for manufacturers of in vitro diagnostic medical devices?
What are the main changes compared to the previous Directive 98/79/EC?
What are the GMP requirements
What is MDSAP?
Marketing in Canada: what are the disclosure obligations required by Directive SOR 98-282?
GMP FDA: which production processes should I validate?
cGMp FDA: when can I exclude the design from my quality system according to the US cGMP?
How many reviews should I expect during the device design ?
How to register radiation emitting medical devices with the CDRH
What is the Accession Number?
Which medical devices are classified as electronic products that emit radiation?
What does the CDRH do?
What is the Product (Initial) Report to the CDRH?
MDR (EU) 2017/745 impact on CE MDD certificates during the “period of grace”
How can I continue to sell my devices after the full implementation of MDR?
What is the “post-market surveillance system”?
What is the “period of grace” and how can I take advantage of it?
What is the difference between market surveillance, post-market surveillance (PMS) and vigilance?
What are the MDR requirements for post-market surveillance, market surveillance and vigilance?