Creating a smooth journey on the long road of medical device development

The medical devices industry is one that continues to grow year after year. Ongoing scientific and medical advancements result in the development of new procedures. These new procedures in turn create the need for new and bespoke equipment.

Developing a new device and bringing it successfully to market can however be a daunting prospect. Seeing the process through to completion requires tenacity and dedication and there are numerous gauntlets that must be passed through.Generally, as advancements continue so does their complexity and the fields in which discoveries are made become ever more specialized.

One of the aspects of medical device development that can be the most time consuming is ensuring the device meets with all relevant regulatory and legislative requirements of the countries in which it will be distributed. Fortunately, most of the largest markets for medical device products such as the US and the EU have comprehensive and over-arching legislation and  regulations that means requirements do not need to be established for member states individually. Even with this factor taken into consideration the process is substantial and can be intimidating especially for new and smaller companies just starting out. Trying to get approval for a first medical device can seem impossible without adequate administrative resources.

Much of this process involves carrying out medical device trials that satisfy the relevant legal requirements. Finding a clinical trials company that gives guidance on navigating the many nuances of the legislation is not just vital but essential to all concerned.

Java CR work with many similar sized CROs around Europe meaning they have a wealth of experience in the development of medical devices and a range of contacts able to provide whatever services may be required.