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. In our interview with Marginum’s CEO and CTO, it was 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 described as highly effective and offered great value for the price, allowing Marginum to access a wide range of expert resources without the need for extensive internal training. Marginum would highly recommend MDS for our flexibility, expertise, and commitment to achieving common goals. The partnership significantly streamlined their path to CE marking and regulatory compliance. If you're interested in hearing more about our services & how we could help your company navigate quality management and regulation, book a meeting here: https://lnkd.in/d8vujjZW #startups #ISO13485 #MDR #medicaldevices #IVDR
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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. In our interview with Marginum’s CEO and CTO, it was 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 described as highly effective and offered great value for the price, allowing Marginum to access a wide range of expert resources without the need for extensive internal training. Marginum would highly recommend MDS for our flexibility, expertise, and commitment to achieving common goals. The partnership significantly streamlined their path to CE marking and regulatory compliance. If you're interested in hearing more about our services & how we could help your company navigate quality management and regulation, book a meeting here: https://lnkd.in/dky_c__A #startups #ISO13485 #MDR #medicaldevices #IVDR
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Quality Check! BAAT has successfully passed the ISO 13485 recertification audit by our Notified Body MedCert with ZERO non-conformities! Why does this matter for you? Navigating MDR compliance (EU Medical Device Regulations) is one of the toughest challenges for Medtech startups. When partnering with BAAT’s MDR-compliant processes, you gain: ➜ A faster path to market, reducing costly delays ➜ Confidence in a robust ISO 13485 Quality Management System ➜ Support for seamless regulatory compliance in the Medtech sector BAAT’s solutions are tailored for Medtech innovators. We help you focus on scaling your business while we handle the complexities of compliance. Ready to accelerate your Medtech journey? Visit us at www.baatmedical.com! #MDR #ISO13485 #MedTech #RegulatoryCompliance #Startups
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Supporting Med-tech Start-ups Start-ups face unique challenges in the medical device industry. Discover how TS Quality & Engineering helps new ventures ensure safety, efficacy, and regulatory compliance from the outset. #Startups #MedTech #RegulatoryCompliance #Innovation Read more: TS Q&E Helping Med-tech Start-ups from the Ground to Succeed
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Supporting Med-tech Start-ups Start-ups face unique challenges in the medical device industry. Discover how TS Quality & Engineering helps new ventures ensure safety, efficacy, and regulatory compliance from the outset. #Startups #MedTech #RegulatoryCompliance #Innovation Read more: TS Q&E Helping Med-tech Start-ups from the Ground to Succeed
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Supporting Med-tech Start-ups Start-ups face unique challenges in the medical device industry. Discover how TS Quality & Engineering helps new ventures ensure safety, efficacy, and regulatory compliance from the outset. #Startups #MedTech #RegulatoryCompliance #Innovation Read more: TS Q&E Helping Med-tech Start-ups from the Ground to Succeed
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Supporting Med-tech Start-ups Start-ups face unique challenges in the medical device industry. Discover how TS Quality & Engineering helps new ventures ensure safety, efficacy, and regulatory compliance from the outset. #Startups #MedTech #RegulatoryCompliance #Innovation Read more: TS Q&E Helping Med-tech Start-ups from the Ground to Succeed
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Supporting Med-tech Start-ups Start-ups face unique challenges in the medical device industry. Discover how TS Quality & Engineering helps new ventures ensure safety, efficacy, and regulatory compliance from the outset. #Startups #MedTech #RegulatoryCompliance #Innovation Read more: TS Q&E Helping Med-tech Start-ups from the Ground to Succeed
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Supporting Med-tech Start-ups Start-ups face unique challenges in the medical device industry. Discover how TS Quality & Engineering helps new ventures ensure safety, efficacy, and regulatory compliance from the outset. #Startups #MedTech #RegulatoryCompliance #Innovation Read more: TS Q&E Helping Med-tech Start-ups from the Ground to Succeed
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Supporting Med-tech Start-ups Start-ups face unique challenges in the medical device industry. Discover how TS Quality & Engineering helps new ventures ensure safety, efficacy, and regulatory compliance from the outset. #Startups #MedTech #RegulatoryCompliance #Innovation Read more: TS Q&E Helping Med-tech Start-ups from the Ground to Succeed
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Another great opportunity to learn more about the interface between medical device design & development and regulatory compliance. I’m sure this will book up quickly so register as soon as you can! #medicaldevices #medtech #regulatory #compliance #eumdr #fda
Join our regulatory partner Psephos Biomedica for their next workshop ‘Concept to Compliance – A Roadmap to EU and FDA Approval’ to show you how to achieve #regulatory #compliance for your product and what you need to do in order to submit to a Notified Body and the FDA. Date: Thursday 27th February 2025 Times: 10:00 - 13:00 Venue: Hill Dickinson Offices, Primrose Street, London, EC2A 2EW Cost: FREE to attend Places are limited so REGISTER now to guarantee your place! 👉 https://bit.ly/4flUEJU #innovators #smes #startups #medtech #medicaldevices #healthtech #regulations #lifesciences #digitalhealth #medicaldevicemanufacturers
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https://mdsfinland.fi/medical-device-services/quality-management-systems-iso-13485/