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, 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 Technical Dossiers and Regulatory Complaince audits for:   

Medical Device Regulation (MDR); (EU) 2017/745)
In Vitro Diagnostic Device Regulation (IVDR); (EU) 2017/746)

 

• Audits/QMS systems

ISO 13485:2016 and ISO 9001:2015

Annex IX of the MDR

Annex IX of the IVDR

21 CFR 820

internal audits

supplier/subcontractor audits

 

• Clinical
  

Clinical Pathway strategy and reviews

Clinical Trials/ Performance 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.