MDQ Services

About MDQ Services

Young and brilliant consulting firm that provides strategic, technical and regulatory services for medical device development. MDQ Services Ltd can help companies understand the current and foreseeable future regulatory environment in Europe and the UK, and how they apply to specific devices, taking into consideration their development timescales and the technical documentation and clinical data requirements for each regulatory jurisdiction. Services: PRRC: Role of PRRC (Person Responsible for Regulatory Compliance). Article 15 of both the in vitro diagnostic medical device regulation (2017/746) and the medical device regulation (2017/745) describe the new obligation that manufacturers and authorised representatives must meet such that they must have at least one Person Responsible for Regulatory Compliance (PRRC) UK Responsible Person: Post-Brexit, from 1 January 2021, the United Kingdom (UK) will transition to a new medical device regulatory system, independent from the European Economic Area (EEA). One of the requirements that will apply immediately, from 1 January 2021, for all non-UK manufacturers, is that a UK-based UK Responsible Person (UKRP) must be designated. Legislation in EU and UK: Helping you understand EU Regulations (EU) 2017/745 (MDR) & (EU) 2017/746 (IVDR), UK MDR 2002 and future UKCA marking requirements. CH REP: Swiss Authorised Representative for Medical Devices (sister company). Quality Management Systems: Planned for your Company. A pragmatic approach to quality management systems to international standards. Experienced quality management systems advice and assistance for medical device companies throughout Europe and UK.

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