Quality & Regulatory
We help our customers enable access to global markets with Quality and Regulatory compliance in our role as Legal Manufacturer.
We provide you with proven regulatory strategies for your digital health projects. Huma Quality and Regulatory Affairs offers a compliant and sustainable Quality and Regulatory framework to support digital health solutions, Medical Device Data Systems and Medical Device Market access. Find out how we support all Medical Device classes via the features below.
Quality Management System which is certified to ISO 13485
Global Regulatory Intelligence to ensure compliance across all countries
Huma STED Technical File to enable market access
Design History File and documentation compliant to IEC 62304 and 62366 requirements
Compliant with IEC 82304 for Software as Medical Device development and product development
EC Certification according EU MDR 2017/745 for Class IIb (CE Mark) and Registrations in US, UK, South Africa, Australia and Saudi-Arabia
Compliance built-in
Our Quality Management System and product are developed and compliant with the following standards and regulations. Our product is certified CE-marked Medical Device (Software as a medical Device). Our extensive experience as a Legal Manufacturer allows us to also support those customers embarking on becoming Legal Manufacturers themselves.
2017/745 CE Class IIb
Medical Device ISO standard & basis for MDSAP
Information Security Management system
FDA Class II
US Food and Drug Administration Medical Device regulation K230214
Software Life Cycle Process
Health Software - Part 1: General requirements for product safety
Risk management ISO Standard
Clinical investigation of medical devices for human subjects
Usability Standard for Software as a Medical Device
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United Kingdom certification scheme for protection in cyber security
Plus
United Kingdom certification scheme independently validated by an accredited third party
Audited and approved supplier to Major Pharma companies (Bayer, S*N, Janssen, Parexel)
Monitoring of global regulatory requirements (EMERGO, Advena, Monitoring of CA websites)
Enabled Market Access by registration with major regulations (US, EU, UK, Middle East, Africa and APAC)
Shanghai
Room 123, 13th Floor
Shanghai Tower
No. 501 Yincheng Middle Road
China
For all China enquiries
Munich
(DACH-Region)
Huma Therapeutics GmbH
Raboisen 32
20095 Hamburg
For all enquiries
