Our Services in Detail
From quality system development to audit readiness, we provide hands-on regulatory and quality support tailored to startup and small medical device manufacturers.
Schedule a ConsultationQuality Management Systems
We build, maintain, and remediate QMS documentation aligned with ISO 13485:2016 and the FDA's QMSR, so your quality system supports growth instead of slowing it down.
- Gap assessments against ISO 13485:2016 and FDA QMSR
- Document hierarchy and controlled document design
- SOP and work instruction development
- CAPA and complaint handling system setup
- Ongoing QMS maintenance and remediation support
Regulatory Affairs & Submissions
We guide submissions and global regulatory strategy so your technical documentation holds up under agency scrutiny in every market you enter.
- 510(k) and De Novo submission preparation
- Technical documentation for EU MDR compliance
- Global regulatory strategy and market roadmaps
- Agency communication and response support
Audit & Inspection Support
We prepare teams for the moments that matter most — mock inspections, supplier audits, and remediation planning that hold up under real scrutiny.
- Mock FDA and ISO 13485 audits
- Supplier qualification and audit programs
- CAPA effectiveness reviews
- Inspection readiness coaching for your team
Startup & Growth Support
Scalable compliance systems and advisory support built for the pace of early-stage and growing medical device companies.
- Right-sized QMS design for early-stage teams
- Compliance roadmap from concept to market
- Ongoing advisory retainers as you scale
Frequently Asked Questions
Straight answers to the questions startup and small medical device teams ask us most often about FDA and ISO 13485 compliance.