.png)
Case Studies
Streamlining MDSAP Certification — Example of a Laser Therapy Ophthalmic Device
Challenges
The start-up faced the absence of an ISO 13485–compliant QMS, no prior MDSAP audit experience, and the need to meet multiple country-specific standards, all while operating under significant time pressure to accelerate market entry and align internal teams with rigorous regulatory expectations.
Solutions
A tailored, MDSAP-aligned QMS was rapidly implemented alongside targeted team training, robust risk management and usability processes, complete technical documentation, and proactive audit readiness activities to fast-track certification across all required markets.
Record-time MDSAP certification
Faster multi-market access (CA, US, AUS )
Increased product credibility
Scalable compliance foundation
Results
CONCLUSION
With expert regulatory guidance and a targeted QMS implementation, this start-up overcame initial inexperience with MDSAP to meet stringent multi-market regulatory demands quickly. This case exemplifies how effective planning and training accelerate regulatory certification.
TESTIMONIAL
"Working with Hasnaa has, and continues to be, exceptional. Hasnaa combines candor, diligence, extensive industry knowledge, and a delightful approach to rapidly resolving regulatory and quality challenges. Her expertise in stewarding our organization through ISO 13485 MDSAP audit(s) in record time without compromising quality, and smoothly implementing our eQMS was invaluable. Hasnaa’s strategic problem-solving skills significantly advanced our compliance and accelerated market readiness, her ability to work quickly and collaboratively is unmatched. I highly recommend her to any entity (startup to established) seeking an outstanding regulatory and quality champion." — Scott Crawley, CEO, Compass HealthAI