Regulatory Affairs

Your partner for regulatory affairs, inmedis Zug

Your business plan failed due to wrong product approval? Not with us! Our experts support you with training, as external resources in projects or even as the "person responsible for regulatory compliance" in day-to-day business, from approval strategy to effective market surveillance:

Approval Strategy

Are you looking for alternatives to the costly initial approval in Europe under the MDR?

We support you in clarifying relevant regulatory issues on the way to a sound regulatory strategy:

  • How long does the registration take?
  • Who are the potential partners for registration?
  • Which documents are required?
  • What costs are involved?
  • And above all: when will which product be registered in which country?

Registrations and approvals

Our experts provide support from the preparation of the required approval documents to the successful registration of your product in various markets (EU, US, CAN, CN, etc.):

  • Introduction of UDI
  • Preparation or review of the registration documents
  • Coordination with authorised representatives, notified bodies, authorities and third parties
  • Registration of your company
  • Registration of your products
  • Monitoring of registration certificates 

 


Post-market surveillance / vigilance

Systematic market surveillance is a key instrument under the MDR and involves considerable effort. However, if implemented appropriately, market surveillance can also contribute to a better understanding of the products on the market. We support you, from the development of effective processes to the assumption of monitoring and reporting activities:

  • Implementation of processes for market surveillance / vigilance
  • Creation of PMS plans
  • Monitoring your products on the market (complaints, reports from authorities, literature)
  • Reporting serious incidents to authorities
  • Support with field safety corrective actions
  • Preparation of internal reports for corporate management
  • Preparation of safety reports (PSUR) for the authorities  

 


Regulatory intelligence

As part of our activities, we continuously monitor the regulatory requirements of various markets and ensure that our experts remain up-to-date. We are happy to share our regulatory knowledge with you and support you with the following services:

  • Definition of appropriate standards subscriptions
  • Periodic information and targeted internal training:
    • Standards
    • EU regulations, directives and guidelines (e.g. MDR, MDCG)
    • Country specific laws (e.g. MPG, FDA laws)
  • Analysis of the impact of regulatory changes on your company
  • Implementation of the regulatory requirements in your quality management system (QMS)
  • Updating your technical documentation