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 (CE mark) and Registrations in US, UK, South Africa, Australia and Saudi-Arabia

Huma complies with the requirements of the EU MDR

Cloud agnostic capability

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.

EU MDD & MDR

EC Directive 93/42 and 2017/745 CE Class I

ISO13485

Medical Device ISO Standard & basis for MDSAP

ISO27001

Information Security Management system

21CFR820 US FDA Class I exempt

US Food and Drug Administration Medical Device regulation

IEC/ISO62304

Software Life Cycle Process

IEC 82304-1

Health Software - Part 1: General requirements for product safety

ISO14971

Risk management ISO Standard

ISO14155

Clinical investigation of medical devices for human subjects

IEC62366

Usability Standard for Software as s Medical Device

CyberEssentials

United Kingdom certification scheme for protection in cyber security

CyberEssentials Plus

United Kingdom certification scheme independently validated by an accredited third party

Approved Pharma Supplier

Audited and approved supplier to Major Pharma companies (Bayer, S*N, Janssen, Parexel)

Regulatory Intelligence

Monitoring of global regulatory requirements (EMERGO, Advena, Monitoring of CA websites)

Global Regulatory Footprint

Enabled Market Access by registration with major regulations (US, EU, UK, Middle East, Africa and APAC)

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