As a Swiss-based regulatory consulting firm, Yodh Research is committed to ensuring that our clients’ medical devices comply with regulatory requirements in Switzerland and the European Union (EU). Our team of experts includes a Person Responsible for Regulatory Compliance (PRRC), who has extensive experience and knowledge in quality management systems and regulatory compliance for medical devices.
Medical device manufacturers who wish to market their products in Europe and Switzerland must have an Authorized Representative (AR) in place to act as a point of contact between the manufacturer and the regulatory authorities. The AR is responsible for ensuring that the manufacturer complies with relevant regulatory requirements and for registering the device with the relevant authorities. The AR must also keep technical documentation and other relevant information about the device on file.
We work closely with manufacturers to ensure that their medical devices meet all regulatory requirements in a timely and efficient manner, allowing them to focus on bringing their products to market. Our team is committed to ensuring that our clients receive the highest level of service and support, helping them to navigate the complex regulatory landscape and achieve compliance with confidence.
At Yodh Research, we understand the importance of compliance in the medical device industry, and we are dedicated to supporting our clients in achieving their regulatory goals. Contact us today to learn more about our Medical Device Authorised Representative services and how we can assist you in bringing your medical devices to market in Switzerland.
At Yodh Research, we offer Medical Device Authorised Representative services, acting as the AR for manufacturers who wish to market their products in Switzerland. Our PRRC ensures that our clients’ medical devices comply with all relevant regulatory requirements, including the EU Medical Devices Regulation (MDR) and the Swiss Medical Devices Ordinance. Our team is equipped with the necessary expertise to provide comprehensive support to manufacturers, including guidance on regulatory compliance, assistance with device registration, and maintenance of technical documentation.