IVDR has significant implications for the manufacturing of IVD devices, as it requires manufacturers to comply with new and more rigorous regulatory requirements. Wiktoria Banczyk, Product Manager Lab Filtration Medical Devices at Sartorius Lab Instruments, discusses the challenges posed by the implementation of EU IVDR 2017/746 and key considerations for manufacturers as they navigate today’s regulatory landscape.
New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
Drop the checkbox mentality and embrace accountability and understanding.
How much do you know about this standard? Review the results.
Part II of the ISO 13485 IQ test digs a little bit deeper into the standard.
Medical device customers can receive audits and certificates to ISO 13485:2016 to align with global regulatory requirements.
The answers are revealed, and they may surprise you.
In Part I of our ISO 13485 test, see how much you know about the basics of the standards.
How to prepare for a successful transition.
Risk Management is the single most important topic impacting the medical device industry today.