Regulatory & Quality consulting built for medical device startups and small organizations.
Getting a medical device to market is hard enough without compliance slowing you down. Regulix Consulting works with startups to build the quality systems, regulatory strategies, and FDA submissions you need. Done right the first time, without the overhead of a full-time hire.
Sound familiar?
"We need a QMS but don't know where to start."
We build ISO 13485 compliant quality management systems from the ground up. Fast, audit ready, and scaled to your stage.
"We received an FDA warning letter."
We manage FDA remediation programs from gap assessment through implementation and FDA response.
"We're preparing our first 510(k) and need help."
We guide first time submitters through the full process from strategy through final filing with fewer rejection cycles.
"We have a product recall and don't know where to start."
We manage recall strategy, FDA notifications, root cause analysis, and corrective action to protect your customers and your company.
"We need regulatory support but can't hire full time."
We act as your outsourced regulatory and quality team. FDA Agent, PRRC, Management Rep, or full regulatory strategy.
"We failed an audit and need to fix it fast."
We develop and execute corrective action plans that satisfy regulators and prevent the same issues from coming back.
What we do
We offer targeted engagements built around what your company actually needs, not a one size fits all retainer.
QMS Build and Remediation
We build quality management systems from the ground up and remediate systems that have failed audits or fallen out of compliance. Whether you need initial ISO 13485 certification, a full QMS overhaul, or targeted gap remediation, we deliver systems that are audit ready from day one.
ISO 13485 · QMSR/21 CFR Part 820 · MDSAP · AS9100D · ISO 9001 · eQMS implementation
Audit Support and FDA Remediation
We support companies before, during, and after audits including internal, supplier, notified body, and FDA. For companies that have received warning letters or 483 observations, we develop and execute corrective action plans that satisfy regulators and prevent recurrence.
FDA Warning Letters · 483 Responses · CAPA · Internal Audits · Supplier Audits · Notified Body Prep
EU MDR and IVDR Compliance
We help companies achieve and maintain CE Mark under EU MDR and IVDR, including technical documentation, clinical evaluation reports, post market surveillance, and notified body audit preparation. We also provide PRRC services for companies without an EU based regulatory lead.
EU MDR · IVDR · UKCA · Technical Files · PRRC Services
FDA Submissions
We prepare and support FDA submissions for Class I, II, and III medical devices from strategy through final filing. We help first time submitters understand the process and experienced teams move faster with fewer rejection cycles.
510(k) · De Novo · PMA · IDE · Q-Sub · Technical Files · Product Dossiers
Management Representative, FDA Agent & PRRC Representative Services
Foreign manufacturers distributing devices in the US are required to designate a US FDA Agent. We provide FDA Agent services and serve as Management Representative or PRRC for companies that need a qualified regulatory point of contact without hiring full time.
FDA Agent · PRRC · Management Representative
Product Recalls
We manage the full recall process including recall strategy, FDA notifications, health hazard evaluations, root cause analysis, and corrective action. We guide you through every step to protect your customers and minimize risk to your company.
Recall Strategy · FDA Notification · Health Hazard Evaluation · Root Cause Analysis · CAPA
Aerospace Compliance
We support aerospace manufacturers through NADCAP accreditation, AS9100D certification, and prime contractor audits across NDT, chemical processing, materials testing, and welding. We have achieved zero findings certifications across multiple facilities.
NADCAP · AS9100D · ISO 9001 · ISO 17025 · NDT · Chemical Processing · Materials Testing · Welding
Why companies choose us.
15+
Years — each consultant brings 15+ years of experience
0
Findings on certification audits
3 mo
ISO 13485, MDSAP, AS9100D, ISO 9001 built from the ground up
4
Industries served - Medical Device, Diagnostics, Cosmetics, and Aerospace
Ready to get started?
Complete the form and we will be in touch within one business day to discuss your situation and recommend the right solution. No obligation.