Regulations and Compliance Med Tech US

HGi,

I dont know whether these will resolve all of your compliance points - but they should be a good “starter for 10”. I found these in the whitepaper section of the IFS website. I believe there could be more relevant to Medical Devices etc…….

Useful?

Hi Victor,

do you know Sotax in Basel / Switzerland? https://www.sotax.com/
They produce dissolution testing for pharma industries.
( SOTAX helps pharmaceutical companies worldwide in overcoming the various challenges associated with feasibility studies, method development, method automation, method validation, and method transfer. )
They startet with IFS last year.
Perhaps you can ask them how the use IFS for compliance issues.
I stay in contact with them for BI issues and can ask them next time we will teams.

cu

Michael

Thank you so much Michael and Gary for your input, really appreciated. 

Anyone who knows where to turn to get a verification that IFS supports it? 

Product performance and safety testing to standards such as:

• IEC/AAMI 60601, Medical electrical equipment - General requirements for basic safety and performance
• IEC 60601-1-2, Electromagnetic compatibility (EMC), wireless testing, coexistence
• IEC 62304, the Standard for medical device software
• ANSI/CAN/UL 2900-1, the Standard for software cybersecurity for network-connectable products, Part 1: General requirements
• ANSI/CAN/UL 2900-2-1, the Standard for software cybersecurity for network-connectable products, Part 2-1: Particular requirements for network connectable components of healthcare and wellness systems

Medical regulatory compliance services, including:

• CE Compliance – MDD, MDR and IVDD certifications (?????)
• Medical Device Single Audit Program (MDSAP) certification
• Quality management system (QMS) registration and certification for medical device manufacturers include ISO 13485 and ISO 9001
• Brazil INMETRO certification 
• ISO 14971, risk management for medical devices registration
• IEC 62304, medical device software — software life cycle processes registration