Medical Device Consulting Services
Expert regulatory and development support across the entire medical device lifecycle
Boyds provides end-to-end medical device consulting and medtech expertise, guiding companies through every stage of development – from early design and feasibility through to post-market obligations.
Our experienced team helps you navigate complex global regulatory pathways, strengthen quality systems, and bring safe, effective devices to market with confidence.
How can we support your medical device development?
Medical device regulatory strategy and roadmaps (US, EU, UK)
We develop clear, actionable regulatory strategies tailored to your device, market, and commercial goals.
Our support includes:
- Regulatory pathway analysis and strategic planning
- Device classification
- Global launch and compliance roadmaps
- Drug device combinations
Navigate EU MDR, IVDR and FDA requirements
We help you interpret and apply evolving EU MDR/IVDR and FDA requirements, ensuring alignment at every development stage.
Our expertise includes:
- EU MDR and IVDR compliance
- FDA regulatory strategy and alignment
- Gap assessments
- Technical documentation review and support
- Regulatory risk identification and mitigation
Market clearance and submission support
Our expert team can tailor the support you need to navigate the submission process, including:
- CE marking under EU MDR
- FDA 510(k), PMA, and De Novo submissions
- Notified Body and Competent Authority engagement
- FDA communication and meeting preparation
Build compliant technical documentation and design controls
We provide tailored support for technical file compilation and design control deliverables, including:
- Risk management in line with ISO 14971
- Design controls and Design History File (DHF)
- Product testing strategy and performance evidence generation
Quality Management Systems (QMS)
We build, refine, and audit Quality Management Systems to support regulatory approval and ensure long-term compliance with ISO 13485 and GxP requirements.
Clinical investigations (UK & EU)
We help plan, prepare, and submit clinical investigation applications (including drug-device combinations), ensuring compliance with regional regulations and supporting seamless trial initiation.
Integrated expertise across devices, drugs and biologics
Boyds offers a unique advantage through our combined expertise across drug, biologics, and medical device development.
This enables:
- Harmonized drug-device development strategies
- Clinical and technical documentation authoring
- Publication and submission support
- Due diligence for assets and acquisitions
- Operational support for clinical trials
- EU Legal Representative services for clinical trials
Speak to our medical device experts today.
Get in touch
If you would like to talk to a member of our team about a specific project or area of expertise, then please complete this form and we will get in touch.