SaMD plays a critical role in modern healthcare and understanding its Regulatory landscape is essential for developers, healthcare professionals, and Regulatory authorities. This whitepaper aims to provide an overview of the Regulatory framework governing Software as a Medical Device (SaMD). It throws light on SaMD classification, Regulatory submission, and approval/clearance process in the USA, European Union, Canada, and Australia.
Freyr provides a very reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team act professionally to execute the work with excellent communication of progress.
-Regulatory and Quality Assurance Manager,
Numedico Technologies
We’re impressed with Freyr’s support in providing us with quick and well-detailed solutions to our queries. Freyr’s constant support to adapt to ever-changing regulatory conditions while providing support with any additional queries we had in a timely manner has truly impressed us.
- Sergey Burlov, Quality Manager,
Inobitec
Freyr has been our reliable Regulatory partner who possess a deep understanding of the technical documentation and has provided us with timely support with gap analysis which led to successful and timely registration of our devices. We are highly impressed with the customer support that we received from Freyr in understanding our queries and providing us with timely and accurate solutions.
- Project Lead, Regulatory Affairs,
A Russian Medical Device Manufacturer
Freyr has been an indispensable partner in achieving rapid global scalability for our software as a medical device business. As a startup, acquiring expertise in world-wide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device regulatory domain.
- Arie Henkin, VP - Quality and Regulatory,
Omniscient Neurotechnology
As a customer of Freyr Software Services Pvt. Ltd, we would like to express our appreciation for the high-quality and efficient work performed by your team in preparation and support of the software registration process in ANVISA. It was made possible to complete the project on schedule and achieve its goal as a result of the presence of highly qualified specialists, an established feedback system, and prompt resolution of any emerging issues.
We look forward to further fruitful and mutually beneficial Cooperation.
- General Director, Regulatory Affairs
Russian Based Healthcare Software Development Company
The team has always been very professional and supportive with our projects and inquiries. Communication was always timely. Knowledge of regulations, open communication, timely follow ups with my team and professionalism. What I wanted to add as a strength yet did not; was the ability to work without sleep. I feel you all work around the clock as you are very responsive on our questions any time of day ?
- Director, Regulatory Affairs,
US based top Sterilization company
You have exceeded our expectations as a team and individuals! Special thanks for all the prepared technical documentation!! What an effort team! Again, many thanks for all the work and efforts put into this, moving forward positively. Thank you for your consistency, perseverance, and amazing teamwork at Freyr. we would like to express our gratitude to the Freyr team for all the great work and expertise that they have brought to the project to make it a success!
- Regulatory Affairs Officer,
A Global Industry Leader in Medical Device Design and Manufacturing
Speed of service, responsiveness, attention to our needs, quality of product, and price are all very important and I felt they were very good in our work with Freyr. Service was delivered appropriately and in a timely fashion. Thankful to Freyr’s responsive team because of which we could comprehend our unusual needs. I thought the support was very good and met with expectations. In addition, found the price reasonable given the workload.
- Director, Regulatory Affairs,
US based leading precision medicine company