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The regulatory frameworks within which medical devices companies operate can be confusing and requirements are often unclear. Our Navigate consultancy service is on hand to provide direction when you need it most. Practically, Navigate is the name we give to a whole range of activities we provide under the umbrella of what is essentially consultancy. Our specialist consultants have expertise in the field of medical devices which enable us to provide reliable interpretations of regulatory and quality requirements, and then to implement effective solutions to allow these requirements to be met.
As part of Navigate, MedRAS provides Responsible Person services. Under the UK MDR 2002, non-Great Britain based manufacturers must appoint a UK based responsible person who is required to undertake a number of critical regulatory functions on behalf of, and in conjunction with the legal manufacturer. Similar requirements apply to manufacturers marketing medical devices under the EU Medical Device Regulations (EU) 2017/745. These are critical regulatory roles which require manufacturers to ensure they assign this responsibility to on-hand, qualified, and competent personnel. MedRAS has implemented processes to provide Responsible person services and holds the required experience, and competence to fulfil these roles fully in-house.
Planning and accountability are key to successful project management, and whatever the project, we can help:
Ground-up design and development of full, new ISO 13485:2016 compliant Quality management systems including establishment of QMS procedures, templates, forms, work instructions and policies and associated tools
Ground-up design and development of medical devices including project management of design projects: from discovery to transfer to production
Technical file formulation
Design history documentation
Risk management file documentation
QMS Software validation
Brexit and MDR gap analysis and transition
Ad hoc and regular, Regulatory and quality support
Notified Body audit preparation
CAPA implementation
Internal audit conduct, reporting and follow up
Supplier audit conduct reporting and follow up
Notified Body transfer support
Quality Management system restructuring
Regulatory optimisation services
MDSAP audit support
MDSAP Quality Management system support
Post Market Surveillance support
Clinical evaluation reporting
Person Responsible for Regulatory Compliance (PRRC) service provision
UK responsible person service provision
Core schemes within our scope of expertise:
Medical Devices Directive 93/42/EEC
In vitro diagnostic medical devices Directive 98/79/EC
Active implantable medical devices Directive 90/385/EEC
The UK MDR 2002 (as amended) - UKCA certification
Regulation (EU) 2017/745- Medical devices
Regulation (EU) 2017/746- In vitro diagnostic medical devices
Regulation (EU) 722/2012- Active implantable medical devices and medical devices manufactured utilising tissues of animal origin
Commission Implementing Regulation 920/2013
Commission Recommendation 2013/473/EU
EN ISO 13485:2016 Medical devices- Quality management systems
The Medical Device Single Audit Program (MDSAP)- Australia, Brazil, Canada, Japan, USA
Get in touch to see how we can support your organisation’s next project.
Company number: 14185746