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.
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.
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:
Seminars and Trainings