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REGULATORY AFFAIRS

Due Diligence

Stricter regulatory requirements on medical device economical operators (i.e. manufacturers, distributors, and importers) pose a major challenge to company acquisition processes. Strengthening your Due Diligence team with a Medical Device Quality and Regulatory expert will increase your chances of a successful project. 

Due Diligence

Our Due Diligence consultants are ready to support your Due Diligence project from a Quality and Regulatory perspective, either on-site or off-site. We investigate and make comprehensive appraisals of medical device businesses, with your specific business perspective in mind. 

Our offer is an investigation to evaluate the QA/RA maturity of medical device products and quality processes for development and manufacturing thereof, in relation to applicable standards and regulations such as ISO 13485:2016, EU Medical Device Regulation (MDR, 2017/745) and FDA 21 CFR Part 820.

Contact us for more information

Meeri Säily
Meeri Säily
Sales Director

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Explore our services

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Regulatory plans

Regulatory plans for medical device manufacturers.

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Technical Documentation

All medical devices must have a set of documentation available to support its compliance to applicable regulations. Aurevia supports you in planning and creating the needed Technical Documentation.

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Electrical Safety IEC 60601

IEC 60601-1 is the basic international safety standard for medical electrical devices and systems.

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Biological Safety ISO 10993

International standard of biological safety evaluation process and preparing biological evaluation documentation for medical device manufacturers.

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IVDR compliance for in-house developed tests

Laboratories developing IVDs in-house must maintain Technical Documentation and Quality Management Systems to comply with the IVDR and the national law.

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IVD Performance Evaluation

In vitro diagnostic medical device (IVD) regulations are set out in the EU In Vitro Diagnostics Regulation.

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Qualification and classification of medical devices

Our team’s versatile experience and the available tools help in bringing clarity to the challenging cases.

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Medical software

Adhering to medical device software regulations throughout the entire lifecycle.

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Risk Management ISO 14971

Setting up and implementing a risk management system and preparing risk management documentation.

Latest news

Read the latest news from the world of quality.

Aurevia appoints Jonna Pelanti as the new Head of EQA business area

We are delighted to announce the appointment of the new Head of the EQA business area Jonna Pelanti.
Meet us at BioMedica in Dublin on 18-20 March.

Meet us at BioMedica in Dublin

Meet us at the BioMedica exhibition at booth A18!

Aurevia appoints Ulrika Hammarström as the new Head of CRO business area

We are delighted to announce the appointment of the new Head of the CRO business area Ulrika Hammarström.
EQA pilot studies in 2025

Introducing the EQA Pilot Studies 2025

Register now for this year's EQA pilot studies! They will be conducted starting in March.

Aurevia appoints Anna-Karin Alm as the new Head of the QA/RA business area

Anna-Karin Alm assumes the QA/RA business area head position in Aurevia and will lead the Aurevia QA/RA organization in...