Our services
Clinical Evaluation
Whether you have a new medical device or established legacy product, demonstrating their performance and safety is critical to any successful interaction with a regulatory stakeholder.
SciMed are experts in finding, screening and appraising meaningful clinical evidence from a wide range of sources in order to prepare the most robust Clinical Evaluations possible for any international market.
Contact us to make sure you have the confidence to successfully navigate the regulatory landscape.
Clinical Maintenance
Once you've prepared you Clinical Evaluation, it's critical that you don't let it gather dust! Our ongoing Clinical Evaluation Maintenance Service ensures continued compliance with international requirements without the associated resource burden.
SciMed will monitor the scientific literature, post-market data, manage PMCF activities, and update Clinical Documentation on your behalf, helping you demonstrate ongoing device safety and performance throughout your product lifecycle.