WHERE IT STARTED
Marginum sought the expertise of MDS to implement a quality management system and assist in the compilation of a medical device technical file. With limited in-house resources and experience in this area, they turned to MDS for support.
Marginum chose MDS for our flexibility, understanding of startup dynamics, and our tailored approach. The experience of working with MDS was described as seamless, with first-class expertise and strong communication throughout the process.
HOW IT HAPPENED
Marginum highlighted that MDS provided valuable guidance, efficiently navigating the complexities of regulatory requirements and ensuring that the quality system certification process went smoothly. This support not only accelerated Marginum’s time to market but also created a structured approach for ongoing system maintenance and documentation.
The collaboration was highly effective and offered great value for money, allowing Marginum to access a wide range of expert resources without the need for extensive internal training. Marginum would highly recommend MDS for their flexibility, expertise, and commitment to achieving common goals. The partnership significantly streamlined their path to CE marking and regulatory compliance.
WHAT DID WE DO?
ISO 13485 Quality Management System implemented
Assisted in stage 1 & 2 certification audits
Assisted in obtaining ISO 13485 certification
Created internal processes for future operations
Technical File for Class II medical device
Clinical Evaluation Report for medical device
Biological Evaluation Report for medical device
Streamlined path to CE-mark and regulatory compliance
WHERE ARE WE NOW?
The impact of working with MDS on Marginum’s business was profound. Our expert advice not only streamlined regulatory processes but also ensured that the company was prepared for future growth and audits. This partnership allowed Marginum to focus on their core product development, knowing that regulatory compliance was in capable hands.
The collaboration with MDS significantly reduced the time and effort required to achieve regulatory milestones, making it possible for Marginum to bring their innovative technology to market much faster.
“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
