Startups — early-stage device companies preparing for ISO 13485 certification, FDA submission, or first supplier onboarding.
Small to Medium-Sized Companies — scaling operations, adding suppliers, or tightening their QMS to meet growth and regulatory milestones.
Tissue Processors & HCT/P Organizations — donor eligibility, recovery site oversight, labeling, and compliance with 21 CFR Part 1271 and AATB standards.
Contract Manufacturers (CMs) — providing assemblies or finished devices under customer ISO 13485/FDA requirements.
Test Labs, Sterilization, Packaging & Labeling Partners — outsourced service providers critical to device release, including sterilizers, packaging suppliers, labeling houses, and accredited testing laboratories.
Software & Digital Health Teams (SaMD / AI in MedTech) — companies developing software-as-a-medical-device, or using AI tools in regulated environments.
Component & Subassembly Suppliers — plastics, metals, electronics, or other parts manufactured specifically for MedTech OEMs.

Medical Device

Aerospace & Defense — AS9100 or ISO 9001-certified shops, including machining, composites, and system integration suppliers.
Electronics / EMS / PCB / Cable & Harness — PCB fabrication, printed circuit assemblies, wire harnesses, and contract electronics manufacturing.
Plastics & Injection Molding — custom molders serving multiple industries, often crossing into MedTech, aerospace, and consumer goods.
Machining, Stampings, Castings & Extrusions — metals suppliers with specialized machining, finishing, or forming processes.
Prototyping Shops — small suppliers building prototypes and early pilot production for MedTech and industrial OEMs.
Packaging, Labeling, Printing, Kitting & 3PL — logistics, distribution, and secondary services supporting OEMs in regulated and unregulated industries.
General Industrial & Multi-Industry Suppliers — contract manufacturers or fabricators that service a mix of medical, aerospace, defense, agriculture, and consumer markets.

Industrial Manufacturing

Internal audits evaluate your company’s own processes and QMS compliance, while supplier audits assess your vendors’ ability to meet product and possibly ISO 13485/9001 requirements. Both are essential for identifying risks and ensuring compliance.
ISO 13485/9001 and FDA 21 CFR Part 820 require suppliers to be re-evaluated periodically, with frequency based on risk. Critical suppliers are often evaluated every 12 to 24 months, while lower-risk suppliers may be on a longer cycle. Perform a risk mapping exercise to determine supplier risk.
Independent auditors provide objectivity, technical expertise, and industry perspective. Engineering-led audits go beyond checklists- spotting gaps in design, operations, and compliance that internal teams may overlook.
Findings are documented in a report and categorized by non-conformity. You’ll need to develop a corrective action plan, track progress, and verify effectiveness to close the finding. After auditing, we can help develop and implement corrective actions, track progress, and verify effectiveness to fully close the findings.