Medical devices are subjected to comply with strict regulatory protocols, as it is vital to ensure the efficacy and safety of medical devices. Therefore, it is compulsory for every device to comply with national and international standards before entering a market. The standard guidelines of medical devices vary from country to country, and it is mandatory for every manufacturer to follow these guidelines for marketing or selling of their products in a country. For example, the United States follows FDA guidelines, Europe considers CE approval, Canada needs Health Canada Registration, and India requires approval from CDSCO. This diverse range of regulatory landscape drives the testing and certification market for aesthetic devices.
Since regulations are different in every country, it is crucial for each medical device manufacturer to register or receive regulatory guidelines of that specific country, which, in turn, indicates the need for authorized third-parties to register their devices. National regulatory authorities of every country prefer that the manufacturers selling their products in that particular country should comply with standard guidelines, and get it checked by a third-party certification system. This can result in propelling the testing and certification market, as well as increase easy market access. The other factors, such as increasing need of validation and verification (V&V) for medical devices are driving the medical device testing and certification market.
Key Market Trends
Testing Services are Expected to Witness Rapid Growth
Medical devices are regulated by various regulatory authorities and compliances. This is mainly because the end-users of these devices expect outstanding performance, effectiveness, and safety from these medical devices. Therefore, it is mandatory for the manufacturers to properly define and implement medical device testing strategy which makes the device effective and production becomes easier due to the confirmation of quality.
An effective medical device testing strategy needs several sets of test requirements. These test requirements are based on the component specification, manufacturing process, and other critical functional specifications of the device. Test requirements define and describe setup conditions, actions, and expected response constraints for each experiment defined in the test steps.
These sets of requirements are required to smoothen test implementation as tests are carried out continuously at different stages of the complete manufacturing process, from component selection to a final assembly of a medical device, and each stage has different requirements and different parameters to be satisfied.
Thus, increasing medical devices will also increase these testing services, which is expected to augment the growth of the market.
North America Dominates the Market
North America dominates the medical device testing and certification market due to the increased focus on the quality of the medical devices and the presence of a large number of companies that serve the medical device industry. In the North America region, the United States is having the largest share in the market and the country is expected to witness a similar trend over the forecast period due to the presence of well-developed healthcare and the presence of top multinatiional medical device companies.
The market is highly consolidated and there are few other companies that are providing the testing and certification services. It has been observed that with the growing medical device market, more companies are expected to enter the market in the near future. Substantial market share will be gained by the small to mid-sized companies in the coming years.
Reasons to Purchase this report:
- The market estimate (ME) sheet in Excel format
- Report customization as per the client's requirements
- 3 months of analyst support