AKKA Life Sciences provides experts on demand as well as a full remote service through its competence centers for the development and certification of medical devices, whatever the class.
Key activities provided by AKKA Life Sciences in this arena include:
For Product Engineering:
- Mechanical engineering
- Plastics processing
- Packaging design
- Development & validation of embedded software
For Project Quality Assurance:
- Development strategy preparation.
- Project management (planning, consultants team, progress report).
- Risk analysis following NF EN ISO 14971.
- Process validation: gamma sterilization, ethylene oxide sterilization, injection, extrusion, marking, packaging (sealing), cleaning, transport.
- Biological and chemical evaluation –including biocompatibility following NF EN ISO 10993.
- Design change.
- Medical electrical equipment: implementation of NF EN ISO 60601 regarding device safety.
- Medical device software: implementation of NF EN ISO 62304 regarding software life cycle processes.
For Quality Systems:
- Document Management Quality (drafting and updating procedures /instructions /forms)
- GMP training
- Support for system validation
- System audit according to NF EN ISO 13485: 2016, NF EN ISO 9001: 2015, 21 CFR Part 820 and MDSAP program by ICA auditors
- QMS creation and setting up
For Regulatory Affairs:
- Support in regulatory strategy: DM classification determining, determining of applicable norms and the Notified Body (NB) for European and international market.
- Writing/proofreading of CE marking, DMF type III, PMA and 510 k.
- Formating and audit of dossiers according to European Regulations 2017/745 and 2017/746 (MD DIV).
- Post-marketing surveillance.
- UDI strategy.