QUNIQUE provides medical device companies with customised solutions for quality management systems (QMS), supporting the implementation of new processes and training personnel appropriately.

QUNIQUE focuses on compliance and efficiency. Its services cover the whole range, from creating a template or a standard operating procedure (SOP) to implementing a full QMS in compliance with ISO 13485:2016, Medical Device Single Audit Program (MDSAP), US Food and Drug Administration (FDA) 21 CFR part 820, or ISO 9001:2015.

QUNIQUE understands the regulatory requirements for medical device manufacturers, including the EU medical device regulation (MDR), MDSAP, and the ISO 13485.

Audit preparation for medical device manufacturers

QUNIQUE incorporates many years of experience in preparing for audits.

The company’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 or audit preparation room, as well as all the required logistics before, during, and after the audit. The firm also provides checklists to make this preparation more coordinated.

QUNIQUE also performs mock audits, gap assessments, internal audits, and supplier audits.

Regulatory affairs services

QUNIQUE helps find the easiest way to get your medical devices market approval. The company 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. The firm provides:

• GAP analysis
• Remediation activities

Seminars and training

QUNIQUE is specialised in organising seminars with top international speakers and subject matter experts.

The company also offers 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

About QUNIQUE

Founded in May 2017 by quality management expert Angelina Hakim, QUNIQUE specialises in developing custom consultation packages, and works with a broad network of partners to support, maintain, and improve compliance in the medical device industry.

The company is focused on the requirements and needs of manufacturers