There is an important and fair reason for having regulations and standards for Medical Devices , IVD and Combination Products to ensure the safety for the patient or the user, and to secure the device is making an real difference for the user. This thinking will help your business grow.
Understanding the final requirements on the product from the very beginning, means that you will be able to set the optimal specifications both on your product as well as on your manufacturing processes and equipment from the start. By doing so, you will for sure avoid costly design changes late in your development process.
The adoption of standards is voluntary but serve as a stepping stone towards a sound demonstration of the safety and effectiveness of your products By identifying and complying with relevant standards, you may work in a more efficient way through having an easy and common language when discussing with suppliers and business partners. This will add value to your business.
Our advisors are experienced in both regulations and numerous standards relevant for the EU and US markets. We also have insight and experience in regulations for other geographical areas such as Canada, Asia, etc.