MDS Finland specialises in quality and regulatory consultation services as well as product development for medical device companies and start-ups. The company offers high experience, competence and know-how so much needed to navigate the heavily regulated market environment.
MDS Finland now offers the due diligence service designed to tackle challenges specific to the medical device industry.
‘Traditional due diligence, in most cases, focuses only on assessing financial risks and benefits. However, for medical device companies, such scrutiny is generally insufficient. This is because, in addition to the financial risks, stringent regulations result in numerous uncertainties about future outcomes and developments. That is why we have designed the due diligence service that provides medical device start-ups and investors with valuable information and helps them make confident funding decisions. Our service also secures broader perspectives on business opportunities‘, said Jani Virtanen, MDS Finland.
The due diligence service focuses on the following areas:
- Intended use of the device
Does the device truly meet an unmet need? Could it potentially have multiple intended uses? How likely will healthcare adopt this device?
- Clinical evidence
Does the device meet regulatory requirements regarding clinical evidence? Does clinical evidence support the proof of concept?
- Company competence profile
Are technical and preclinical development expertise sufficient? How about networking? Is there a need for consultant help regarding the regulatory pathway?
- Regulatory strategy
Are resources sufficient to plan and implement the regulatory strategy? How much will the regulatory pathway cost? Which markets are worth entering and when?
- Risk management:
Current state-of-the-art and the technical basis of the device: what kind of technical or planning implementation risks are there? How likely will the device achieve the desired market response? What kind of post-market risks are there and how can they be minimized? How long will it take for the device to become widespread in the market?
Read more about the due diligence service and see how your company can benefit from it. https://www.linkedin.com/feed/update/urn:li:activity:7094965816839802880
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