Who We Serve
Medical Devices, Medical Supplies and Medical Equipment. Only.
We work only with companies in the medical device supply chain: the firms that design, make, label, import, distribute, reprocess and service the products patients and clinicians rely on. Staying in one field is how our advisors know what your auditor will ask.
Our Scope
Who We Work With, and Who We Don't
If your product is regulated as a medical device, or you make, move or service one, you're in the right place.
- Medical device manufacturers, Class I through Class III
- Medical supply and consumables manufacturers
- Medical equipment manufacturers, from capital equipment to home-use devices
- Specification developers who outsource manufacturing
- Contract manufacturers, component suppliers and contract sterilizers
- Relabelers, repackagers and kit assemblers
- Distributors, importers and private-label distributors
- Reprocessors, refurbishers and remanufacturers
Outside our scope
- Pharmaceuticals and biologics, except the device side of a combination product
- Food, dietary supplements and cosmetics
- Manufacturing outside the medical supply chain
- Medicare DMEPOS supplier accreditation
- Clinical laboratory accreditation (CLIA, CAP)
By Device Class
Class I Device Manufacturers
Know which exemptions really apply to your Class I device, and keep the records that still do.
Class II Device Manufacturers
For 510(k) and De Novo device makers whose design, change and risk records need to agree with each other.
Class III Device Manufacturers
For PMA applicants and holders facing pre-approval inspections, supplements and postmarket obligations.
Medical Equipment
Electromedical and Capital Equipment
For powered and capital equipment: electrical safety, usability, installation and service records.
Diagnostic Imaging
For imaging system and image software makers managing installed bases, software updates and cybersecurity.
Durable Medical and Home-Use Equipment
For hospital beds, mobility aids, patient lifts, respiratory equipment and other devices used at home.
By Technology
Software as a Medical Device and AI-Enabled Devices
For software device teams: lifecycle records, cybersecurity, release control and AI model management.
In Vitro Diagnostics
For IVD makers balancing analytical claims, stability evidence, specimen studies and the EU IVDR.
Combination Products
For drug-device and biologic-device combinations working across two sets of quality requirements at once.
Wearables and Digital Health
For connected health hardware and app makers where claims, firmware updates and consumer supply chains meet.
By Clinical Area
Implantable Devices
For devices that stay in the body: long-term biocompatibility, unit traceability and patient records.
Orthopedic Devices
For orthopedic implant and instrument makers: machining, cleaning, instrument reprocessing and deep catalogs.
Cardiovascular Devices
For catheter, valve and cardiac rhythm device makers working under close clinical and postmarket scrutiny.
Dental Devices
For dental device and material makers: reusable instruments, digital workflows and dealer channels.
Ophthalmic Devices
For contact lens, intraocular and ophthalmic instrument makers with tight optical and residue controls.
By Business Model
Contract Manufacturers and Component Suppliers
For contract manufacturers and component suppliers answering to many customers' audits and agreements.
Startups and First-Time Submitters
For first-time device companies building a QMS in phases, starting with design controls and submissions.
Established Manufacturers Expanding to New Markets
For US manufacturers adding MDSAP, EU MDR or IVDR, or ISO 13485 certification to an FDA-focused QMS.
Distributors and Importers
For distributors, initial importers and private-label distributors with complaint, reporting and traceability duties.
Relabelers, Repackagers and Kit Assemblers
For firms that relabel, repackage or assemble devices into convenience kits and procedure packs.
Reprocessors, Refurbishers and Servicers
For single-use device reprocessors, remanufacturers, refurbishers, servicers and OEMs writing reprocessing instructions.
Specification Developers
For firms that design and own a device but have it made by a contract manufacturer.
Next Step
Your Product, Your Audit, Your Timeline
Tell us what you make or move and what's ahead, and an advisor will scope an assessment for it. Please don't send confidential documents yet: secure upload is set up after onboarding.
