FAQ

We support medical device and in vitro diagnostic (IVD) manufacturers of all sizes, from startups building their first quality system to established companies expanding into new markets or responding to regulatory findings.

Our team brings over 25 years of industry experience, including more than 7 years at a notified body auditing quality systems, assessing technical documentation, and serving as a global technical expert for ISO 13485, ISO 9001, MDSAP, FDA 21 CFR Part 820, and the EU MDR and IVDR. We understand both what manufacturers face day to day and what auditors and assessors are looking for.

We support FDA QMSR (21 CFR Part 820), EU MDR and IVDR, UK medical device regulations, ISO 13485, ISO 9001, ISO 14971, MDSAP, and country-specific requirements for global markets.

The initial consultation is a 90-minute session where we review your current quality system, regulatory status, and goals, identify key gaps and risks, and outline a clear path forward. You'll receive a written summary of our findings and recommendations.

The initial consultation is $500. If you book a project engagement within 30 days, the full fee is credited toward your project.

Every project is different, so consulting, remediation, audit, and retainer services are quoted individually based on your needs and scope. Training programs range from $500 to $5,000 depending on the package selected. Contact us for a tailored quote.

We understand that FDA 483 responses are time-sensitive, as FDA expects a response within 15 business days. Contact us as soon as possible and we'll prioritize getting you the support you need to prepare a thorough, well-structured response.

Yes. We build right-sized, practical quality systems designed around your products and team, meeting regulatory requirements without unnecessary complexity or bottlenecks.

Yes. We can serve as your U.S. Agent, Official Correspondent, or both, acting as your point of contact with FDA and helping keep your registration and listings current. Contact us for pricing.

Yes. Our retainer services give you flexible, on-demand access to expert quality and regulatory support without the cost of a full-time hire. Retainers are tailored to your business.

Yes. We offer ready-to-deliver training on topics including ISO 13485, ISO 9001, FDA QMSR, MDSAP, EU MDR/IVDR, risk management, CAPA and root cause analysis, and internal auditing. Custom training tailored to your processes is also available.

Both. Many services can be delivered remotely, and we also provide on-site support for audits, assessments, and training where needed.

No consultant can guarantee an outcome, as regulatory authorities and certification bodies make independent decisions. What we can promise is expert guidance, thorough preparation, and practical support that puts you in the strongest possible position.

Confidentiality is fundamental to everything we do. All client information is held in the strictest confidence, accessed only by those who need it, and never shared without your consent unless required by law. We're also happy to sign an NDA before any engagement begins.

Most services, including consultations and training, are paid in full prior to or at the time of service. Where we agree to invoice, such as for ongoing consulting or retainer work, payment is due within 30 days of the invoice date.

Simply book your initial consultation or contact us to discuss your needs. We'll help you find your clear path to compliance.