Audit preparation for medical device manufacturers

 

QUNIQUE incorporates many years of experience in preparing for audits.

QUNIQUE`s certified ISO 13485:2016 and MDSAP lead auditors can train your personnel to successfully prepare for an audit, including setting up an audit room and audit preparation room, as well as all the required logistics before, during, and after the audit. QUNIQUE also provides checklists to make this preparation more coordinated.

We also perform mock audits, gap assessments, internal audits, and supplier audits. 

Regulatory Affairs services

We help find the easiest way to get your medical devices market approval. QUNIQUE works with experienced and reliable international regulatory professionals in Europe, the US, Asia-Pacific (APAC), and the Middle East (MEA) to support you in the conformity assessment process and international registrations. QUNIQUE provides tailored MDR preparation packages including GAP assessment, technical documentation update (STED), and trainings.

 

Compliance Project Management

QUNIQUE’s project managers can lead your compliance projects or programmes in preparation for an audit or as a result of audit findings. We provide:

 

  • GAP Analysis
  • Remediation activities

 Seminars and Trainings

QUNIQUE is specialised in organising seminars with top international speakers and subject matter experts. We also offer customised, in-house training on various quality and regulatory topics, including:

 

  • Medical Device Regulation
  • Medical Device Regulation With Deep Dive in Clinical Evaluation Expectations
  • Medical Device Regulation With Deep Dive in Post Market Surveillance
  • Medical Device Regulation With Deep Dive in Technical Documentation
  • MDSAP Training for Auditees including Audit Preparation
  • ISO 13485: 2016 Training for Auditees including Audit Preparation