Medical Device and Diagnostics Regulatory

Move your device or IVD to market with a clear regulatory path and submission-ready documentation

BioBoston supports end-to-end medical device and diagnostics regulatory work from FDA pathway strategy and submissions to EU MDR/IVDR technical documentation and post-market compliance, so you reduce risk, avoid rework, and stay audit-ready.

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Device and IVD regulatory specialists (FDA + EU)
Submission-ready deliverables and clear timelines
Supports startups through commercial-stage teams
Flexible support: strategy, execution, or surge capacity

Who this is for

This service is a fit if

You’re unsure whether 510(k), De Novo, PMA, or IDE is the right FDA path
You need to build or fix your EU MDR/IVDR technical documentation
You’re preparing for Notified Body interactions and want fewer surprises 
Your team needs help with CER/PMCF, PMS/PSUR, vigilance, or risk management 
You want labeling and UDI done correctly to avoid launch delays and field issues

What you’ll get

Regulatory pathway strategy (FDA and/or EU) with clear milestones 
Submission plans and document lists aligned to your device/IVD class and claims 
Drafted and reviewed submission content (as applicable) 
EU MDR/IVDR technical documentation support and NB readiness guidance 
Post-market compliance package (PMS plan, PSUR support, vigilance workflows) 
Risk management and design controls alignment to standards and expectations 
Labeling/IFU/UDI support that matches your claims and regulatory requirements

What we do

Our Medical Device and Diagnostics Regulatory support can include:

FDA IDE strategy and support (where applicable)
510(k) submission support (planning, content, and responses)
De Novo pathway support (strategy, dossier support, interactions planning)
PMA support (strategy, content support, and readiness planning)
EU MDR / IVDR technical documentation (including Notified Body interactions support)
Clinical Evaluation Report (CER) and PMCF planning support
Post-market surveillance support (PMS plan, PSUR support, vigilance workflows)
Risk management (ISO 14971) and design controls support
Labeling for devices/IVDs (IFU, labels, UDI alignment and readiness)

Why BioBoston

Device and IVD programs often lose time due to unclear pathways, documentation gaps, and late-stage rework.
We help you build a clean regulatory foundation early linking intended use, claims, evidence, risk controls, and labeling so your submissions and technical documentation are consistent, defensible, and easier to maintain post-market.