There is an important and fair reason for having regulations and standards for Medical Devices, IVD, and Combination Products. It ensures the safety of the patient or the user, and securing the device is making a real difference for the user. Having this in mind will help your business or project grow.
Understanding the final requirements of 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.
Standards as a stepping stone for safety and effectiveness
The adoption of standards is voluntary but serves 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 to the EU and US markets. We also have insight and experience in regulatory affairs for other geographical areas such as Canada, Asia, etc.