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
Commercialization
» 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
%
