Medical Device Design
Wanting to produce cloud based connected healthcare and medical devices but struggling to navigate the interoperability and regulatory requirements? We are expert in international medical device regulations, Security and Privacy with years of hands on design and implementation, we can help! Having designed and developed multiple healthcare and internet connected medical device solutions we have a range of architectural patterns and strategies that are proven to work.
We can provide flexible engagements that aim to overcome your challenges but handover to your companies own people. Anything from initial stage 1 scoping projects all the way to interim CTO positions so that new strategies can be formed to align with your vision and new ways of working developed to fit with your team. We have experience of developing and working within highly regulated environments that are audited to standards such as ISO 13485:2016. We can provide internal audits and gap analysis AND advise you on strategies to achieve CE marking and FDA clearances at the appropriate time and only when necessary. Fundamentally our consultants like to understand and solve your problems.
We examine what organizations are doing to take advantage of new opportunities and technologies and help develop roadmaps to managed success whilst encouraging highly agile delivery within flexible strategies to achieve your long term vision. We look to identify product roadmap strategies that facilitate easier and less regulated pathways to specific markets that allow for earlier market entry and monetisation whilst providing customer engagement experience and data that can be supportive of subsequent clearances.