Simed Global is a specialist medical device company consisting of industry experts with long and successful track records in selling and commercialising medical devices and invitro diagnostics. We have broad functional and sector experience and would welcome an opportunity to discuss with you any challenge relating to creating sustainable value from medical technologies.
Simed Global provides partnership and guidance for the development of your products with an ISO 13485 Quality Management System to ensure that your product or service meets the complex regulatory requirements in your major markets. We can help you register and launch your medical devices and software into the market and new territories. Our services include regulatory advice all the way through to sales and distribution strategies and implementation..
Too many start-ups fail as they do not understand the complexity of the regulatory environment and waste valuable time and resources developing products that cannot be sold because of this. This is an ethical issue as good products that could help improve and sustain the life of patients never get to the market, or get there late, sometimes too late for our loved ones.
Through our established global network and expertise in the Medical Device Business, we look to partner with outstanding companies to find the best selling strategy, in order to bring their innovative and medical solutions to market and new territories.
We classify and register your medical devices across all continents and develop the regulatory plan. We find the best option for you to either own your personal registration or enter into collaboration with a hosting partner.
Finding the best and especially trustworthy partner to be your distribution partner is often one of the biggest challenges in foreign territory. We will make sure to identify companies and professionals matching your requirements and objectives and with whom we already have a proven track record
If you are a manufacturer of Medical Devices and you are based outside the EU or UK you are required under the EU directives or UK Legislation to appoint an Authorized Representative or Responsible Person.
Simed Global can act as your Authorized Representative or Responsible Person in both Europe and also within the UK.
We are able to offer the service of operating as your Representative in either the EU or the UK.
New medical device and IVD regulations in the European Union impose strict new requirements on manufacturers and elevate the role of the importer (Economic Operator) in placing devices on these markets. The regulatory Importer is similar to an EU Authorized Representative, and you must appoint one. There are many reasons to select Simed Global to act as your single independent importer for all European markets.
You will always be able to rely on us as your partner guiding you through each step in “turning dreams into reality”