Our global registrations team is the perfect partner for medical device manufacturers seeking smooth, timely and cost-effective registration of their medical devices internationally. We have the proficiency and 20 years of experience to help you comply with the varying regulatory requirements in all countries worldwide.
The international registrations process can be costly, time-consuming and unpredictable for medical device manufacturers. With our proven process we provide support by managing the compilation and preparation of all necessary documents as well as coordinating with local authorities.
Regardless of your product portfolio and choice of countries, our proprietary software REGULA™ allows active monitoring and responding to all innovations in every single market worldwide. It supports our team of specialists throughout the registration process including document compilation, preparation and coordination, and registrations. It enables us to keep track of the status and progress of registrations in different countries and to take timely actions.
The RA team needs to keep track of all national and international regulations and ensure that all requirements are met in order to distribute the product in various countries. ISS has a comprehensive worldwide knowledge management system that allows us to create RA intelligence tailored to your company enhancing your RA processes more efficiently, as our team always stays informed about all regulatory changes and updates in all countries.
years of experience
medical devices registered worldwide
countries, where we register medical devices
What kind of services does ISS AG offer in the area of global registrations?
How does ISS AG ensure that the takeover of approvals runs smoothly and that there are no delays?
How long does it take on average to obtain an international medical device registration?
Are there any restrictions regarding the type of medical devices?
Is ISS AG active worldwide or limited to certain regions?
How does ISS AG manage to keep track of regulatory changes worldwide?
Whether a product or an entire product range - our international registration team ensures that your products can be safely and efficiently registered and marketed in different countries. We will be happy to advise you. Contact us via contact form, by e-mail or directly by phone. We look forward to supporting you!