Services

Services

mi-CE consultancy offers several consultancy services for medical device manufacturers, in vitro diagnostic devices, and related companies (suppliers) to guide you trough the mash of regulatory requirements for entering the market.

 

Due to the broad experience of the project managers, mi-CE consultancy can offer all the consultancy services you require through the whole process of registration: From basic pre-clinical testing requirements, like, performance testing, biocompatibility, sterility to extensive steering in clinical testing strategy and/or business and regulatory pathway strategies.

 

mi-CE consultancy will assist Medical Device and In Vitro Diagnostic Device manufacturers in their needs for regulatory and quality assurance requirements to comply to the laws and standards.

 

mi-CE consultancy Services :

 

  • CE-marking compliance

Consultancy for Design History Files/ Technical Dossiers and regulatory complaince audits for:   

Medical Device Directive (MDD)
In Vitro Diagnostic Device Directive (IVDD)

 

  • Audits/QMS systems

ISO 13485:2003 and ISO 9001:2008

Annex II, Annex V of the MDD

Annex IV and VII of the IVDD

internal audits

supplier/subcontractor audits

 

  • Clinical

Clinical Pathway strategy and reviews

Clinical Trials design and evaluation

Guidance/contact with several clinical departments in leading hospitals

 

Detailed descriptions of mi-CE consultancy services can be found in the underlying chapters.