Database

Synergio B.V.

Solution provided
Marketing
Supplier identity
General description

Synergio provides products and services to help you manage the entire product life cycle of your medical (MD) and in vitro diagnostics (IVD) devices . Regulatory services to support your company to enter the Dutch market quickly and Software-as-a-Service to manage your entire product life cycle, including demonstrable regulatory compliance.

Type of Supplier
Service Provider - Professional Advisor /Consultant / Legal / AccountingIT/ Software Solutions Provider
Sector of activity
  • Information Technology
  • Regulatory Requirements
Region
Province of Noord Brabant, NL
Regional access broker
  • Ria Hein, Noord-Brabant Development Agency (BOM)
Activity description
Services provided

The implementation of a software package - Cockpit - to manage the entire development process including requirements management, test management, risk management, meeting management, knowledge management, compliancy management.
Assistance in determining which regulatory applies to the new medical device or IVD, which tests need to be developed and run to demonstrate compliance.

Synergio offers different products. For you as an In2LifeSciences partner Synergio have created 2 quick start packages:
1. Regulatory compliancy check for The Netherlands
Do you want to bring your locally approved MD/IVD to the Dutch market? Synergio provides a 3 day assessment to identify which Dutch regulations are applicable for your product. With this information you are able to make a well-considered decision to enter or not enter the Dutch market.

2. Software-as-a-service pilot
Synergio offers a software system, called Cockpit. This software system enables you to manage the development and compliancy of your MD/IVD. You can manage requirements, bill of materials, clinical tests and test results, risks (FMEA) and mitigations and post market surveillance (PMS) including all traceability to proof regulatory compliance. This is the perfect solution for a smooth registration process.

Targeted countries

Netherlands, Belgium, Germany

Market expertise
Expertise in product development, product management, systems engineering, requirements engineering. Our expertise is independent of the region and can be applied world wide
Training and Staff possibilities
No
Contact information
Name
Edwin
Surname
Schumacher
Function
Director
Phone number
+31 (0) 6 5539 2010
Address
Sint Michielsgestelseweg 8
5261 NH  Vught
Netherlands