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
- 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 evaluation planning (CEP)
- Clinical evaluation reports (CER)
- Post-market clinical follow-up (PMCF)
- Compliance check of clinical claims
- Quality management system audits
- Internal audits
- Supplier audits
- Subcontractor audits
- Post-market surveillance systems
- Trend monitoring
- Periodic safety update and summary reports
- Complaint handling and vigilance
Competence and Training
- Gamification of training
- Online training
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 >
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.
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.