Services

Services

Benefit from our RA QA services

Our Services

Regulatory

Our regulatory affairs services offer consultancy on:

CE Marking.

Directives MDD/MDR

IVD/IVDR, AIMD, MD, LVD

EMC, ROHS, REACH, red ETC.

Applications/registrations: FDA

Gap analysis (Product standard)

Due diligence

Build technincal file

Project Manager

Moderator in workshops for

e.g. Risk/Usability standard

Set up Regulatory strategy

Regulatory Affairs Manager

Various support for test house issues

Participate as RA/QA during development

Investigations


Quality

Our quality expertise is extensive and covers:

Participation in development projects

Gap analysis (process)

Quality System build

Quality Assurance Manager

Issue SOP/process documents

Investigations

Participate in audits

Lead Auditor

FDA mock-up audit

Various support for test house issues




Education

As a co-founder and instructor at MEDQURE, I instruct a number of courses. Also, we offer a wide range of courses to companies and staff in Scandinavia.

Due Diligence

We can participate in due diligience activites prior to a potential acquisition when evaluating a target company or its assets for an acquisition. We can evaluate the companys' regulatory and/or quality status and provide valuable feedback.

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Do you require urgent assistance?

00 46 730 70 10 44