Software as a Medical Device (SaMD)
Software that diagnoses or treats on its own — risk-classified under the IMDRF framework and cleared like the device it is.
Explore the categoryProduct Categories
What you’re building decides how you’re regulated.
Classification, center jurisdiction, and the evidence bar all follow from the product in your hands. From SaMD to sterile injectables to gene therapy, our consultants have led programs in every category below — under the framework that governs it.
- 6Product families
- 36Product categories
- US + EUFrameworks we run
The Directory
Find what you’re building.
Six product families, 36 categories. Each entry names the regime that governs it — and links to the expertise that moves it.
Digital Health
Healthcare TechnologySoftware-driven products under FDA’s digital health framework, IEC 62304, and EU MDR Rule 11.
Artificial Intelligence (AI/ML)
Adaptive algorithms under lifecycle oversight — predetermined change control plans, GMLP, and the EU AI Act boundary.
Explore the categoryClinical Decision Support (CDS)
Where the Cures Act carve-out ends and device regulation begins — intended use decides which side you’re on.
Explore the categoryDigital Therapeutics (DTx)
Prescription software with treatment claims — device-grade clinical evidence, human factors, and payer-ready endpoints.
Explore the categoryMobile Medical Applications
Apps that range from enforcement discretion to full device controls, depending on what the label promises.
Explore the categoryConnected Medical Devices
Networked, interoperable hardware — software lifecycle, wireless coexistence, and post-market patching duties.
Explore the categoryRemote Patient Monitoring (RPM)
Home-use sensors feeding clinical decisions — usability for lay users, alarm design, and data integrity end to end.
Explore the categoryCybersecurity
Section 524B premarket submissions, threat modeling, SBOMs, and the vulnerability-management duties that never end.
Explore the categoryMedical Devices
Medical DevicesClass I through PMA hardware under FDA QMSR and EU MDR — design controls to post-market surveillance.
Implantable Devices
Long-term implants carry the highest evidence bar — biocompatibility, fatigue, and lifetime surveillance obligations.
Surgical Systems
Instruments and integrated platforms where human factors and sterility carry the file.
Design Controls & DHFDrug Delivery Systems
Pens, pumps, and autoinjectors — device engineering reviewed under a combination-product rulebook.
Combination ProductsImaging Systems
Diagnostic hardware and its reconstruction software, cleared as one system with performance data to match.
Robotics
Surgical and rehabilitation robots — autonomy, haptics, and human-factors questions with thin precedent.
Wearables
From wellness band to medical-grade monitor, the claim — not the hardware — sets the regulatory pathway.
Patient Monitoring Systems
Bedside, central-station, and ambulatory monitors — alarm management under IEC 60601-1-8 and human factors for continuous use.
Sterile & Single-Use Devices
Sterilization validation, pyrogenicity, and the industry-wide EtO transition.
Sterility Assurance & Annex 1Diagnostics
In Vitro DiagnosticsAssays, analyzers, and the evidence behind every result — the FDA IVD regime and EU IVDR.
In Vitro Diagnostics (IVD)
Assays and instruments under 21 CFR 809 and the EU IVDR’s risk classes — with the clinical evidence to hold a claim.
EU MDR & IVDRMolecular Diagnostics
PCR and NGS-based testing — analytical validity proven at the sequence level, panel by panel.
Companion Diagnostics
Tests that gate a therapy — co-developed with the drug and reviewed in parallel.
Companion Diagnostics strategyPoint-of-Care Diagnostics
Near-patient and CLIA-waived testing — robustness evidence for results in untrained hands.
Pharmaceuticals
PharmaceuticalsSmall molecules to sterile injectables under cGMP and the ICH quality guidelines.
Small Molecule Drugs
NDA and generic programs — CMC depth from route of synthesis through launch and lifecycle.
Regulatory CMCBiologics
BLA-path proteins and antibodies, where the process defines the product and comparability is strategy.
Biosimilars
Analytical similarity first — then interchangeability strategy and reference-product logistics across markets.
Biosimilar StrategyVaccines
Licensure-scale programs with lot release, potency, and post-approval commitments built in.
Infectious Disease & VaccinesInjectable Therapies
Sterile fill-finish, container closure integrity, and Annex 1 compliance from clinical supply onward.
Oral Solid Dosage Forms
Tablets and capsules — dissolution, stability, and the lifecycle changes that keep a franchise compliant.
Topical & Transdermal Products
Locally acting products where bioequivalence takes design — IVPT, IVRT, and adhesion data.
Inhalation & Nasal Drug Products
OINDPs — device-dependent delivery with combination-product data expectations.
Respiratory & PulmonologyAdvanced Therapies
Advanced TherapiesLiving products reviewed at CBER under 21 CFR 1271 and the EU ATMP regulation.
Cell Therapy
Autologous and allogeneic programs where the process is the product and comparability never stops.
Advanced TherapiesGene Therapy
Vectors, durability, and long-term follow-up — high stakes with precedent still being written.
Cell & Gene Therapy QualityTissue-Engineered Products
Scaffolds plus cells — where 361 versus 351 jurisdiction decides the entire program.
Regenerative Medicine
RMAT designation and expedited pathways for products that restore, replace, or regenerate.
Advanced Therapies industryEmerging Technology
Combination ProductsProducts that straddle regimes and pull two rulebooks into one submission.
Combination Products
Drug-device and biologic-device programs — lead-center assignment, 21 CFR Part 4, and cross-labeled duties.
Combination Products serviceBiomaterials
Novel materials with characterization and biocompatibility burdens that precede any clinical claim.
Explore the categoryNanotechnology
Nanoscale materials the agencies review case by case — characterization is the file.
Explore the category3D Printing
Additive manufacturing from patient-matched implants to point-of-care printing — process validation and design-file controls carry the submission.
Explore the categoryStraddling more than one category? The best products usually are.
Tell us what you’re building and the milestone in front of you. We’ll match you with consultants who have taken that product category through the pathway that governs it.