Everything You Need for Successful Certification

International Companies

For companies with existing international certification seeking fast European market access.

• Gap analysis & roadmap
• Documentation adaptation
• Accelerated NB process
• Authorized Representative

Startups

For innovative startups building certification from scratch with funding optimization.

• Technical File creation
• QMS implementation
• Clinical evidence strategy
• Funding-optimized planning

EU Representation

Legal EU representation for non-EU manufacturers.

• EUDAMED registration
• Vigilance management
• Post-market surveillance
• Regulatory updates

Quality Management

ISO 13485 quality management systems built or adapted for EU MDR.

• System definition
• SOP creation
• Gap analysis
• Internal audits

Audit Preparation

Preparation and accompaniment through the certification audit.

• NB selection
• Application preparation
• Mock audits
• Nonconformity management

Clinical Evaluation

Efficient clinical evaluation approach for your product.

• Literature review vs. study
• CER creation
• PMCF planning
• Budget optimization

Production Setup

EU-ready manufacturing setup with qualified suppliers and scalable processes.

• Supplier qualification
• Production transfer support
• Process validation
• Quality agreements

MDR Technical File

Complete Annex II and III documentation built for efficient NB review.

• GSPR and evidence mapping
• Risk management file (ISO 14971)
• Labeling and IFU compliance
• PMS and PMCF documentation

Biological Safety

ISO 10993 biocompatibility strategy and documentation for EU MDR compliance.

• Biological evaluation plan
• Test plan and lab support
• Toxicological assessment
• Biological evaluation report

Study Execution

Pragmatic EU clinical studies to generate MDR evidence fast and cost-efficient.

• Protocol and CIP
• Ethics and authority filings
• Site setup and monitoring
• Clinical study report

Compliance Testing

Efficient testing coordination to meet EU standards and avoid retest cycles.

• EMC testing
• Electrical safety testing
• Pre-compliance checks
• Test report review

Team Enablement

Practical training to build internal MDR and ISO 13485 capability.

• MDR essentials
• ISO 13485 fundamentals
• Internal auditor training
• PMS and vigilance training

Product Development

Development support aligned with design controls and technical documentation needs.

• Hardware development
• Firmware development
• Design controls setup
• Verification support