Our Services

The Regulatory Resource (TRR) focuses on 3 primary areas of specialization:

  1. Regulatory Submissions for Medical Devices (i.e. FDA, CE Mark & More)

  2. Clinical Medical Writing for Medical Devices (Clinical Evaluation, Literature)

  3. Quality Systems & Auditing (ISO 13485, MDSAP, FDA Inspection, EU NB)

See Service Offerings Below.

Regulatory Submissions

  • FDA 510(k) submission preparation and support

  • Premarket Approval (PMA) preparation, supplements, and annual reports

  • Investigational Device Exemption (IDE) submissions

  • FDA Pre-Submission and Pre-Amendment Device Determination

  • Emergency Use Authorization (EUA) preparation

  • EU MDR 2017/745 CE Marking strategy and submissions

  • Technical File/Design Dossier creation and remediation

  • Clinical Evaluation Report (CER) writing and strategy

  • Letter to File (LTF) creation and submission justification

  • Labeling and IFU review, approvals, and regulatory sign-off

  • FDA Medical Device Reporting (MDR) compliance

  • Global product registration (LATAM, APAC, EMEA)

  • ANVISA (Brazil) submissions and deficiency response

  • COFEPRIS (Mexico) product registration and renewals

  • TGA (Australia) submission support

  • Health Canada registration strategy and communication

  • EU IVDR 2017/746 compliance support

  • FDA 483 and Warning Letter remediation strategy

  • FDA inspection preparation and defense

  • Change control regulatory assessment and notifications

Clinical Medical Writing

  • Clinical Evaluation Reports (CER) per MEDDEV 2.7/1 Rev 4 and EU MDR

  • Post-Market Clinical Follow-up (PMCF) plans and reports

  • Post-Market Surveillance (PMS) plans and reports

  • Clinical Literature Search Protocols and Reports

  • Data extraction and critical appraisal for literature reviews

  • Clinical Evaluation Protocol and Plan development

  • Technical rationale writing for submissions

  • Authoring scientific and regulatory white papers and publications

  • Database setup and search strategy for systematic literature reviews

  • Labeling claims substantiation with clinical data

Quality Systems & Auditing

  • ISO 13485:2016 QMS implementation and auditing

  • 21 CFR 820 Quality System Regulation (QSR) compliance

  • Medical Device Single Audit Program (MDSAP) readiness and auditing

  • Internal auditing and audit readiness training (ISO 19011)

  • Supplier auditing and qualification

  • Corrective and Preventive Actions (CAPA) investigation and effectiveness

  • Mock FDA and Notified Body audits and audit defense

  • FDA 483 and Warning Letter response and remediation

  • Quality system gap assessments and roadmap planning

  • QMS documentation: SOPs, templates, work instructions

Ready for a FREE consultation?

Reach out today:

Email us at Thomas.regulatory@gmail.com

Or Call or Message Us:


+1 435 258 8221 SMS / WhatsApp / Cell / iMessage