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Pursue links With best recommendations
DECURA quiub GmbH https://quiub.de Digital requirements and compliance management, across industries (automotive, medical technology, food, information security, supply chain ...)
DEKRA Certification GmbH https://www.dekra.de/de/audit/ Not only cars, but also audits!
Ulrich Pannek https://www.iso-zertifikat.de Consulting and ISO 9001 certification
Pannek Consulting https://www.iso-zert-zeitarbeit.de QMS specifically for temporary employment agencies
Stephanie Niemann https://www.securebiss.de Information security, technical consulting and pen testing
John Institute https://www.johner-institut.de/ The guru in Germany
Vorest AG http://vorest-ag.com Great courses
information links Details
GMP guidelines at a glance and with perspective https://www.gmp-navigator.com Good Manufacturing Procedure, Good Distribution Procedure, etc.
FDA: 21 CFR part 820, Quality System Regulation https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 Similar to ISO 13485
FDA: Medical Devices; Quality System Regulation Amendments (Proposed Rule) Preliminary Regulatory Impact Analysis https://www.fda.gov/media/156552/download
FDA: 21_CFR_part_807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807
Medical Device Single Audit Program - MDSAP https://www.fda.gov/media/87544/download
Medical Device Regulation EU 2017/745 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20200424
FDA: 21 part 822 Post Market Surveilance https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-822
FDA - Medical Devices https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H
EU - Eudamed2 - Info https://health.ec.europa.eu/medical-devices-sector/directives/market-surveillance-and-vigilance_en#which-information-is-stored-in-eudamed2
EU - Medical Devices https://health.ec.europa.eu/medical-devices-topics-interest_de
EU - Eudamed https://webgate.ec.europa.eu/eudamed/landing-page#/
Beuth-Verlag for standards https://www.beuth.de/de
Estonian Center for Standardisation https://www.evs.ee/en/
information links details about it
ITIL v3, ITIL 4th Edition - The framework that explains IT processes embedded in business https://www.axelos.com Information Technology Infrastructure Library
COBIT 5.0, COBIT 2019 - The framework for IT processes and governance https://www.isaca.org Control Objectives for Information and Related Technology
Federal office for security in the information technology https://www.bsi.bund.de/DE/Home/home_node.html Excellent source of information
Alliance for Cyber Security BSI https://www.allianz-fuer-cybersicherheit.de/Webs/ACS/DE/Home/home_node.html Excellent source of information
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