What we offer
Your CH REP
on-demand - dedicated expert
The details
- Client owns budget
- Invoiced monthly at a fixed rate
- Working against task order
- On-site availability of expert
- Mid-term assignment
best used for:
- Start-up's and established companies
- Companies not willing to open a subsidiary in Switzerland
- Restricted budget
- Medical devices of EU Class I, I* and IIa
- Bridging gap till opening a subsidiary in Switzerland
As a service, Avanti Europe will act as the Authorized Representative for your medical device(s). The medical devices will have to be marketed in full compliance with the Medical Device Ordinance Regulation (MepV) and partially with MDR 2017/745.
Our experts will support you in compiling all necessary documentation and data for a successful authorization. As a authorized representative under the MepV, Avanti Europe will need access to at least the following:
- Declaration of conformity
- Technical Documentation
- Reports on conformity assessment according to MDR
- Certificates
- Amendments and supplements of documentation
- EUDAMED registration proof
How it works
The mechanics
tuning to your demand
The details
- Client defines products
- Client defines frequency of information exchange
- Digital data exchange to support EU registration
- Back-traceable reporting
Required Information (as per MDR):
- Declaration of conformity per product
- Technical file per product
- Amendments and supplements to documentation
- Change and CAPA log and procedures
- EUDAMED entry proof
Avanti Europe acting as your Authorized Representative in Switzerland requires a constant and close exchange of information and documentation for reporting reasons to authorities. A digital solution to access and exchange documentation is the best choice.
An Avanti Europe expert will act as the single point of contact (SPOC) in all belongings towards the client.
The costs
The price tag
optimized cost structure
The cost details
- Depending on process landscape
- Depending on number of products
- Depending on number of outsourced manufacturing steps
- Depending on work-load
- Invoiced as a monthly fixed rate
Cost structure:
- Transparent costs
- Simple billing structure
- Scalable with small price steps
Costs are transparently fixed at the beginning of a term. A term can be individually defined or prolonged.
Depending on the volume of documents and number of products, the costs will be representative of the real efforts of maintaining the product on the Swiss market. Depending on demand, further development, expansion of the market or alike, the authorized representative resource can be easily scaled to the demand.