of Agile Methodologies For SaMD With E2E Traceability
Carefully designed by leading medical-tech professionals, this is the only place you need to come to for your business goals. Your medical device will get to the market through us quickly and grow steadily.
Your entire Medical Device
& SaMD development
- Robust and user-friendly document management to store everything in one place. And we have in-built digital signatures too!
- Access hundreds of ready-made SOPs and templates across QMS, DHF and technical files – all compliant with medical industry standards
- Navigate through a one stop boutique for QARA, including Design Control, Change Requests, CAPA, NC, Cyber Security, Clinical Evaluation, Training, Supplier Management and much much more
- Fully compliant design control for medical device and SaMD
- Maintain a design and development file for each medical device
- Generate records to demonstrate conformity
- Records for design and development changes
- Automatic tagging to the technical files
- Automated technical file creation for the CE (MDR/UKCA), MDSAP and 510K submissions
- Seamless implementation of Agile Methodologies for Software as a Medical Device development in compliance with IEC 62304.
- Requirement (Backlog) Management, Design & Development sprint, Testing sprint, Defect fixing sprint, Risk management and Cybersecurity.
- Ensure compliance with all relevant SaMD (Software as a Medical Device) and Medical Device design standards and guidelines with ready-made checklists, including: ISO 14971:2019 – Risk, IEC 62366 –
- Usability, IEC 82304 – Product Validation, AAMI TIR-57 – Cyber Security, plus many more