MedTec experts from development to market
Bringing a medical device to market means mastering strict regulations, quality systems and clinical evidence. Our network covers the complete device lifecycle, from product development to post market surveillance.
Describe your project in a short brief. Our AI matches it against experienced MedTec professionals.
MedTec areas we cover
Product Development & Human Factors
ISO 14971 risk management, usability/HFE, DFx, prototyping & verification
Clinical & Regulatory Affairs
EU MDR, FDA 510(k)/De Novo/PMA, clinical evaluation/PMCF, health-authority interactions
Software & Digital Health
SaMD scope, IEC 62304 lifecycle, cybersecurity (IEC 81001-5-1), interoperability (HL7/FHIR), privacy
Manufacturing & Quality
ISO 13485 QMS, supplier quality, verification/validation (V&V), DMR/DHF/DHR, change control
Post-Market Surveillance & Vigilance
UDI/EUDAMED, complaint handling, CAPA, trend reporting, field safety actions/recalls
Commercial & Market Strategy
Go-to-market, pricing & reimbursement pathways, KOL engagement, channel/distribution strategy
Typical roles we place
A selection of roles our MedTec experts take on. Your brief can describe any role or skill set.
How you can engage our experts
Interim
A full time expert for a defined period. Ideal to bridge a leadership gap or drive a critical phase of your project.
Fractional
Senior expertise for a share of the week on an ongoing basis. You get experienced leadership without a full time hire.
Project based
A defined scope with clear deliverables. From audits and gap assessments to submissions and validation work.
Find your MedTec expert
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