Services

The following services are offered to help companies stay on track when it comes to quality, safety, and compliance

Regulatory Affairs

EU CE marking (MDR (EU) 2017/745 and IVDR (EU) 2017/746)
FDA product registration
Developing and implementing regulatory strategy for new development projects and markets with the main focus on EU and US markets
Training

  • EU CE marking per MDR (EU) 2017/745 and IVDR (EU) 2017/746, gap analysis
  • Technical documentation creation, evaluation and remediation
  • FDA product registrations, listings, document gap assessments, letters to file, GUDID database data entry and maintenance support
  • Defining and implementing regulatory strategy for new product developments and/or markets
  • Device classification
  • Post-market surveillance
  • Document review ( e.g., product and process verifications and validations, biological risk assessment, software validations)
  • Labelling design, marketing material creation assistance
  • Unique Device Identification (UDI) and EUDAMED support
  • MDR (EU) 2017/745 and IVDR (EU) 2017/746 training
  • FDA product registrations training

QMS/Quality Assurance

Compliance with ISO 13485, FDA QSR, MDR (EU) 2017/745, IVDR (EU) 2017/746
Design – implementation – evaluation – optimization – remediation
Training
Electronic QMS (eQMS) implementation and customization

  • Designing and implementing QMS and its processes
  • eQMS implementation and design assistance
  • Defining and implementing QMS procedures (SOPs) and form templates required to market your medical device in compliance with the relevant regulatory requirements
  • Design control process implementation
  • Helping to develop your Mission, Vision, Quality Policy, and creating your Quality Manual
  • Audit/inspection readiness assessment
  • QMS integration assistance for mergers and acquisitions
  • Remediation of audit/inspection non-conformities and 483s (incl. supporting root cause analysis, definition of actions and effectiveness evaluation)
  • Risk management per ISO 14971
  • Supplier management
  • Training on ISO 13485 and FDA QSR requirements

Auditing

Audit management and support

  • Performing internal audits
  • Conducting supplier audits
  • Mock audits
  • Support during external audits and FDA inspections

PRRC role

Acting as external PRRC for micro and small enterprises per MDR (EU) 2017/745

  • Acting as PRRC for micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC per Article 15 of MDR (EU) 2017/745

Connecting Experts

Covering all your project needs

  • I work closely with other independent consultants and subject matter experts within the areas of Clinical Affairs, Biocompatibility, Sterilization, Design and Development and Clean Room Environment. You can therefore be supported by a team that has worked, learned, and succeeded together to cover specific requirements and strategies for your product. This approach saves you time, money and ensures a safe product for patients and health care professionals.
Contact Me