Medical Device Services

Medical device services to meet your needs

We can help you to safeguard the regulatory compliance of medical device manufacturers and importers by:

  • providing you with professional and experienced staff
  • building, maintaining and developing your quality system so that it meets the requirements of applicable standards (ISO 13 485, ISO 14 971)
  • auditing your quality system and subcontractors
  • creating and updating your standard operating procedures and process descriptions
  • training your staff

Clinical expertise

  • Clinical evaluation / clinical evaluation report (CER) and its updates
  • Risk management plan
  • Post-market clinical follow-up (PMCF)
  • Compliance check of device claims

Life-cycle management – post-market surveillance

  • Taking care of trend monitoring and periodic summary reports associated with safety and hazardous situations
  • Handling incident reporting and helping to plan corrective measures and design of safety data sheets
  • Acting as a contact link between the manufacturer and importer

Technical documentation

  • Compilation of technical documentation
  • Helping with classification of your device

 

 

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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Regulatory Affairs        

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