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.
Company Details
- Employees
- 2
- Address
- Flat 81, Seacon Tower, 5 Hutching’s Street, London,england E14 8jx,united Kingdom
- Industry
- International Affairs
- NAICS
-
International Affairs
- Website
- https://www.mdqservices.co.uk/
- HQ
- London, England
Mdq Services Ltd Questions
Mdq Services Ltd's website is https://www.mdqservices.co.uk/
Mdq Services Ltd's LinkedIn profile is https://uk.linkedin.com/company/mdq-services-ltd
Mdq Services Ltd has
2 employees.
View email and phone details for 2
employees at Mdq Services Ltd.
Mdq Services Ltd's industry is
International Affairs
Mdq Services Ltd's top competitors are
Ankers,
Ipq Tecnologie,
Axcent Company,
Ani Pharmaceuticals, Inc.,
Microport Crm,
Arenal Medical,
Amgen Italia,
British Airways,
Élite Med Group Sagl,
Thermo Fisher Scientific.
Mdq Services Ltd's categories are International Affairs
