Navigate - consultancy

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.

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