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Quality & Regulatory
We develop and deploy medical devices to meet the stringent standards set by our clients and regulatory agencies. Our time-tested methods and processes, are fully compliant with FDA and ISO standards including the Quality Management System (QMS), Design History File (DHR) and Device Master Record (DMR). We have assisted numerous organizations in their submissions for IRB, 510(k), De Novo and PMA.
Learn more about our Capabilities
Areas of Expertise:
- Streamlined flexible QMS to fit any size company while following FDA guidance and ISO 13485
- 70+ templates to cover documents required for DHF and DMR
- Comprehensive QMS documentation aligned with FDA and ISO
- Produce technical files required for regulatory submission
- We have assisted companies in developing software technical files where none existed
- Compliance and Certification:
- Design control, 62304 software process, 14971 risk management, 60601-1 certification process
- Relevant collateral standards: UL, NRTL, CE, CB scheme, leading to Safety Mark
