SaMD (Software as a Medical Device) | Regulatory strategy | Design to Sale regulatory assistance | Regulatory Training | Database Maintenance
Regulatory staffing-Interim and Permanent
Breaking Barriers for Complex Markets
Knowledge & Quality:
We have a team of experts specialising in Medical Engineering, Software as a Medical Device (SaMD), with several years of medical device regulatory industry experience.
Reliable & On Time:
We could deliver projects for you with short deadlines and assist you in meeting your targets within the deadline.
Cost-effective Solutions: We care about our clients; we work with you on your budget to provide a suitable solution for both parties. We pride ourselves in providing service better than industrial standards.
Launch a Medical Device
To launch a medical device in a country, medical devices must comply with the local country regulatory requirements. The purpose of these requirements is to demonstrate that products are safe and effective prior to clinical use. OMC Medical offers regulatory support to assist MedTech companies in ensuring safe and effective use of medical devices for local and international markets. We assist you right from design and development to analyse the regulatory compliance requirements. Next is the manufacturing stage, up until the post-market stage for medical device approval. Our primary objective is to provide end-to-end regulatory solutions that enable medical device manufacturers to deliver exceptional health care with cost-effective solutions. OMC Medical offers regulatory support for innovative start-up organisations and also thriving establishment medical device organisations.