Regulatory Strategy & Transition Planning
For new devices we support the definition of regulatory strategies and plans from proof of concept (POC) to market clearance in your chosen territory. With you, we plan device design & development, environment controls to meet ISO 14644, manufacturing / assembly, (including contract manufacturing), packaging & labelling / UDI, sterilisation and change to regulatory applications and product launch & distribution.
For existing devices, we support manufacturers, distributors and other economic operators to establish effective MDD / IVDD to MDR / IVDR transition planning to address and meet the new EU regulations (EU) 2017/745 (MDR) & 746 (IVDR), new EN / ISO standards and/or common specifications. This support extends to Notified Body selection and / or change.
Providing expert resources to advise, develop, plan, implement best fit practices and controls for:
POC including technology application re: clinical need, indications for use and application
Specification development, definition, including User and Interface Requirements
Risk Management planning & identification of national and international standards for test
Notified Body Application / Change
Materials specifications & selection
Materials testing protocols including characterisation, biocompatibility, physical / mechanical / chemical attributes
Clinical Evaluation
Specific country applications / clearances
PMS & Vigilance Planning
Expertise
We have developed regulatory strategies for SME’s, Plc’s, University Spin Outs, start up micro enterprises, SME’s, &Â Global Enterprises to define and implement plans for successful regulatory clearance in Europe, Asia, Australasia, North & South America.
We have and continue to prepare and implement strategies and plans for:
- Transitioning to MDR / IVDR
- Product rationalisation & Risk Management
- BREXIT options:
- Clearance in other countries
- Assessing validity of:
- Supply sources including Importers
- Fulfillment & Distribution networks
- Clinical performance & clinical evaluation data
- Quality management systems
- Compliance control
- Management & organisational capability
- Transition plans
- Budget, time and resources to meet regulatory changes
- Re-location & Transfer
- Change of Materials / Device
- Selecting & changing Notified Bodies
- EC Certificate re-assessment to maximise time to trade in EC
