Medical Device Services

Medical device services tailored for your needs

Our in-country organization will help in safeguarding the regulatory compliance of medical device manufacturers, distributors, EU authorized representatives and importers by:

  • ensuring your compliance with EU Medical Device Regulation
  • supporting you in CE-marking, labeling and localization
  • building, developing and maintaining your quality management system, ISO13485
  • auditing your quality management system
  • performing your supplier and subcontractor audits
  • conducting clinical evaluations and clinical follow-up for you
  • carrying out post-market surveillance, complaint handling and vigilance activities for you
  • providing training for your staff

 

EU MDR

  • GAP analysis
  • Readiness assessments
  • Safety and performance requirements
  • Person responsible for regulatory compliance

 

CE-marking and technical documentation

  • Compilation of technical documentation
  • Technical documentation reviews and assessments
  • Classification of your device
  • Labeling and localizations

 

Quality Management System

  • Risk based approach
  • Standard operating procedures
  • Process descriptions
  • Scaled to your size and role

 

Clinical

  • Clinical evaluation planning (CEP)
  • Clinical evaluation reports (CER)
  • Post-market clinical follow-up (PMCF)
  • Compliance check of clinical claims

 

Audits

  • Quality management system audits
  • Internal audits
  • Supplier audits
  • Subcontractor audits

 

Post-Market Surveillance

  • Post-market surveillance systems
  • Trend monitoring
  • Periodic safety update and summary reports
  • Complaint handling and vigilance

 

Competence and Training

  • Gamification of training
  • Online training
  • Webinars
  • Classroom

 

Are you looking for person responsible for regulatory compliance or Quality Manager? Please ask for more details on our in-sourcing services!

 

 

Medical Device Services to Meet Your Needs

We are dedicated to providing our clients with the very best pharmaceutical and medical consultant services. In the rapidly evolving pharmaceutical industry, we help our clients overcome the challenges they may have ahead.

As a result of our dedication and expertise, we can offer services with confidence. Read more about our pharmaceutical and medical services >

Medical Device Service Biocodex

 

 

 

 

Get To Know Our PhaMe Professionals!

PhaMe team is an enthusiastic and experienced group of professionals working with high commitment and joy.

We provide expert services more than 100 customers annually.

Read more about PhaMe team members

 

Marketing and sales – PARTNERING

We faciliate the market access, distribution and sales of our partner’s pharmaceutical and over-the-counter products in the Nordic and Baltic markets.

Read more of PARTNERING

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