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21 CFR 820 · ISO 13485 · CE Mark · Audits

Quality Systems Built
for Real Compliance.

From QMS design and ISO 13485 implementation to CE Mark technical files and internal audits — we build quality systems that satisfy regulators and actually work in practice.

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Overview

A quality management system is the foundation of every successful medical device company. Done well, it ensures product safety, supports regulatory submissions, and protects you during FDA inspections. Done poorly — or assembled purely to pass an audit — it becomes a liability. We build systems that are both compliant and practical.

21 CFR Part 820 — FDA Quality System Regulation

We design and implement quality systems fully aligned with FDA's Quality System Regulation, incorporating the harmonized ISO 13485:2016 standard.

  • Gap analysis against current QSR requirements
  • SOP and work instruction development
  • Design controls implementation (21 CFR 820.30)
  • Document and records control systems
  • CAPA, complaint handling, and MDR procedures
  • Management review and internal audit program
  • Supplier qualification and control procedures

ISO 13485:2016 Certification Support

Whether you are pursuing initial ISO 13485 certification or maintaining an existing certificate, we support every stage of the process.

  • QMS design aligned with ISO 13485:2016
  • Notified body audit preparation
  • Internal audit execution and reporting
  • Management review facilitation
  • Surveillance audit remediation support

ISO 13485 certification is a prerequisite for CE Mark in the EU and is increasingly expected by US hospital system procurement.

CE Mark & EU MDR Technical Files

The EU Medical Device Regulation (MDR 2017/745) demands significantly more rigorous technical documentation than its predecessor. We prepare complete technical files aligned with Annex II and III requirements.

  • Device description and specification
  • Clinical evaluation report (CER) coordination
  • Risk management file (ISO 14971)
  • Post-market surveillance (PMS) and PMCF planning
  • Declaration of Conformity
  • EUDAMED registration support

Internal Audits

Our independent internal audit service gives you an objective, experienced assessment of your QMS — the same perspective FDA or a notified body would bring.

  • Full QMS internal audit against 21 CFR 820 and/or ISO 13485
  • Audit report with finding classification and remediation guidance
  • Mock FDA inspection simulations
  • Audit program design and auditor training