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Medical Device 

MDR enforcement has left many companies unprepared to implement all the required assessment and technical documentation.

Get help for experienced professionals with experience in R&D, Regulation and Quality in the Medical Device Industry

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Technical Files

Get all the documentation ready for your Medical Device to be submited for regulatory compliants. Obtain your CE marking

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Risk Assessment for the development of Medical devices

Our risk assessment based on ISO 14971 will highlight and document all the risk related to your medical device and have it ready to get the CE marking

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SME in pharmaceutical formulation

Consult an expert in pharmaceutical formulation and analythical chemistry for pharmaceutical products


Let's understand the clinical risk of your device and literature review wiht our Clinical Evaluation Report

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Quality System  for Medical device ISO 13485

Complaint Management

Non Conformancies and CAPA Reports

Change Control Planning

KPI Identification and tracking system


Supplier Management

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SME in dressing for wound care management 

Consult an expert in adhesive, product design, tensile strenght and more

Science Lab
Science Lab

Technical Support for  formulation and analysis of Pharmaceutical Product

  • Get help on R&D projects for pharmaceutical formulation and analysis

  • Review of technical documentation and laboratory requirements 

  • Expert in HPLC and analytical chemistry

  • Data Analysis

  • Reports for licence variation

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