Thorough competencies of the regulation 21 CFR Part 820 (and is monitoring the coming [2025] QMSR) and regulation ISO13485:2016

21 CFR Part 820 is essentially a part of a substantially larger set of regulations and mindset of medical devices: https://www.ecfr.gov/current/title-21/chapter-I

..comprising all types of matter in contact with human beings.

21 CFR Part 820 is an American regulation (in Swedish: “en lag”; in Danish “en lov”) supervised/overseen by FDA and its 1 700 employees. Violation of this regulation is not only costly, but also detrimental to your business, since FDA is able to close your business for the Americal market.

The regulation concerning ‘drugs’ — 200 to 499 — is based on the same principles as Part 820, but is far more complex, requiring extensive statistical knowledge and profound chemical competences; INSAKATO acknowledge the challenges of this area but is able to support in e.g. Subject matter expert for any medical device

a.       In a cGMP environment (part 210): current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general

b.      Part 211: current good manufacturing practice for finished pharmaceuticals

c.       Part 600—biological products: general

d.      Part 878: Wound care; general and plastic surgery devices

e.       Part 1271: human cells, tissues, and cellular and tissue-based products

We have also been involved in different market approvals directed by FDA: 510(k) and PMA, and is hence able to guide and direct You from our experiences. We are though not able to run an entire PMA process, but is proficient as subject matter experts in regulations and profound physics and statistical methods.

ISO1348:2016 is the fundamental standard of medical device for Europe. An organisation may either set up a complex and distangled quality system or approach your system development or alteration by the basis KISS (Keep It Simple [Stupid]); INSAKATO is able to support your business with the latter.