# Regulatory consulting: audits, QM systems, claim review | INOPREX

> Regulatory consulting at INOPREX: audit preparation ISO 13485 and ISO 22716, gap analyses, claim review, training and interim PRRC roles.

Quelle: https://inoporex.de/en/leistungen/regulatory-consulting/

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## Regulatory consulting for audits, QM and claims

Audit preparation ISO 13485 and ISO 22716, gap analyses, technical documentation, claim review, training and interim PRRC roles.

Regulatory consulting at INOPREX supports manufacturers and brand owners with all regulatory matters around medical devices, cosmetics and food supplements: audit preparation and accompaniment with notified bodies, authorities and customer audits, internal and supplier audits, building QM systems under ISO 13485 and ISO 22716, gap analyses and remediation, technical documentation and PIF, claim review, plus training and interim PRRC roles.

**Audit preparation and accompaniment**

Preparation for audits by notified bodies, authorities and customers — including on-site support, findings processing and evidence handling.

**QM systems: ISO 13485 and ISO 22716**

Building, developing and re-implementing QM systems — fitting the product category, without overengineering.

**Gap analyses and remediation**

As-is assessment against MDR, ISO 13485:2016 or Regulation (EC) No 1223/2009 with a prioritised action list and implementation support.

**Technical documentation and PIF**

Creation and maintenance of technical documentation per MDR Annex II/III and of the Product Information File for cosmetics.

**Claim review**

Review of advertising claims under EFSA requirements, the Health Claims Regulation and the cosmetic claims Regulation (EU) No 655/2013.

**Training and interim PRRC**

Team training and interim occupation of the person responsible for regulatory compliance (PRRC) role under Article 15 EU MDR.

## Request an initial consultation

Describe your situation in the briefing — we will respond within two working days with an effort assessment.