Medical Device Compliance

Medical device compliance, done with care.

ISO 13485 audits, Quality Management, Regulatory Affairs, and Information Security — for medical device companies who want depth without overhead.

ISO 13485 audits → All services
Pulse to checkmark A jagged pulse line representing regulatory complexity, resolving into a bold checkmark — patient safety meets compliance done right.
Mindful Minimalism
Led by a certified practitioner —
  • ASQ CMDA
  • ASQ CMQ/OE
  • RAPS RAC
  • Securiti AI Governance
Our practice

We provide Quality Management, Regulatory Affairs, and Information Security expertise — with a minimum-viable mindset, modern tools, and a deep respect for the work.

Services

What we do.

i.

Quality Management

Deploy ISO 13485 & FDA QMSR-compliant systems quickly — built to be lived in.

  • Designing and implementing quality management controls
  • Developing job descriptions and screening applicants
  • Training staff on key topics
  • Selecting and deploying software tools
  • Hosting FDA, notified body, and client audits
  • Responding to client questionnaires
  • Reviewing contracts and statements of work
  • Integrating quality and information security management controls
  • Selecting contract manufacturing organizations and other vendors
  • Conducting independent 21 CFR Part 11 certifications and internal audits
ii.

Regulatory Affairs

Strategy and submissions that move with you — from classification to clearance.

  • Crafting regulatory strategy for various markets
  • Submitting 513(g) requests for classification and pathway confirmation
  • Facilitating pre-submission meetings
  • Submitting 510(k)s and resolving findings promptly
  • Providing targeted guidance for software development and cybersecurity
  • Coordinating establishment registration and listing
  • Submitting medical device reports
  • Acting as U.S. agent and initial importer
  • Selecting third-party test labs (e.g., electrical safety, disinfection)
iii.

Information Security

Safeguard data, reduce risk, and meet the standards your customers expect.

  • Designing and implementing information security and privacy controls
  • Training staff on key topics
  • Selecting and deploying cybersecurity tools
  • Hosting registrar and client audits
  • Responding to client questionnaires
  • Reviewing contracts and statements of work
  • Integrating quality and information security management controls
  • Selecting penetration testing and other vendors
  • Supporting threat modeling and risk analysis
  • Leading incident review and remediation
Audit Services

ISO 13485 audits, modernized.

Fixed-price ISO 13485 internal audits and certification readiness assessments for medical device startups — led and signed off by an ASQ Certified Medical Device Auditor.

Internal Audit From $3,500
Gap Assessment From $7,000
Expedited Available
Explore audit services →
Values

How we work.

i.

Working on meaningful and affordable devices

ii.

Providing multiple solutions for market access

iii.

Designing solutions with a minimum-viable mindset

iv.

Leveraging modern tools and approaches

v.

Operating with integrity and respect

Get in touch

Let’s talk about your compliance.

Whether you’re a startup standing up your first QMS or an established team navigating a 510(k), we’d be glad to hear from you.

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