Who are we?

MDS  is a specialist organization that was established in 2015 to serve medical device manufacturers, distributors and importers. Our company offers its clients all the experience, competence and know-how needed to survive in the heavily regulated market environment.

We offer comprehensive services across quality management, regulatory affairs, clinical research, and commercialization, designed to support every stage of your product lifecycle.

Our Services in Brief

Medical Device Services

Quality Management

Quality Management Systems

Quality Manager Service

Person Responsible for Regulatory Compliance (PRRC)

Internal Auditing for Quality Management Systems and technical Files

Technical Documentation

Medical Device Technical Files for EU CE Mark

Clinical Evaluation Reports (CER) under the EU MDR

FDA Approval Process for Medical Devices

Consulting

Quality Assurance and Regulatory Compliance Consulting

European Authorized Representative

Medical Device Testing IEC60601

Medical Device Testing ISO10993

Trainings

CRO Services

Clinical Trial Project Management

Professionally Qualified CRA Staff

Good Laboratory Practice (GLP) Studies

Auditing Services and Quality Management for Clinical Trials

CRO Services

Regulatory Strategy Services

Reimbursement Services

Medical Device Due Diligence

Medical Device Market Analysis

Why Choose MDS Finland?

Efficient Flexibility

Tailored services for every stage in the medical device market, from start-ups to major corporations.

Extensive Expertise

Decades of deep regulatory knowledge and market insight in the medical device industry.

Comprehensive Services

Full-spectrum support from regulatory compliance to commercialization throughout your product lifecycle.

Tailored Solutions

Customized strategies ensuring regulatory success and market entry for your unique needs.

Global Reach

Expertise in navigating EU, US, and global regulatory landscapes, ensuring compliance with all standards.

Commitment to Excellence

Focused on quality, safety, and compliance to meet the highest industry standards.

What they say about us?

“Absolutely can 100% recommend it”

With limited internal experience and resources, external expertise is needed to navigate the complexities of regulation and quality management effectively – A lot of things are new, the way of doing things on the regulatory side is different… It’s been a big challenge to get into.

Without support, it would be a long way to satisfy regulation. MDS accelerated the process and created a ready-made approach on how to operate and maintain the system.

Juho Leskinen
Chief Technology Officer
Marginum

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How we have succeeded?

Projects Completed

QMS's Setup

Technical Files

Technical files in 2023

FDA Submissions

%

Success rate in 2023