Medical Devices

Diagnosis, treatment and prevention of diseases.

Several players are involved in designing, developing, manufacturing and marketing medical devices. They can be public, such as hospitals or research centers, or private, such as clinics and manufacturing industries.

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Services Careers

Services

We provide support in the following aspects:

Engineering, Verification & Validation Quality & Regulation

Engineering, Verification & Validation

Biomedical Engineering

Committed to the continuous improvement of hospital and industrial services, our engineers are involved in acquiring, installing and maintaining medical devices (equipment, materials, etc.) used to treat diseases, in full compliance with the biomedical sector standards.

  • Management of biomedical engineering projects.
  • Management of the ISO 13485 standard.
  • Need analysis and drafting of specifications.
  • Layout plan for medical equipment.
  • Update of the CDR.
  • Compliance with OHS standards.
  • Technology watch and continuous improvement.
  • Audit and remediation plan.
  • Validation, monitoring of deliverables and deadlines.
  • Regulatory watch: FDA, Health Canada…
  • Staff training.
  • Multi-disciplinary collaboration.
Verification & Validation

Through verification, we check the compliance of specifications for the proper functioning of devices or processes. Then through validation, we assess if user needs are met, while ensuring the systemic reproducibility of results.

  • Management of biomedical validation projects.
  • Management of the ISO 13485 standard.
  • Bugs troubleshooting.
  • Verification and validation of specifications.
  • Risk analysis: FMECA, QbD approach…
  • Audit and remediation plan.
  • Regulatory watch: FDA, Health Canada…
  • Staff training.
  • Multi-disciplinary collaboration.
R&D Engineering

In response to the many operational challenges faced by hospitals and health centers, we provide R&D engineering in the design, development and improvement of medical equipment, in an innovation-minded approach.

  • Management of biomedical R&D projects.
  • Management of the ISO 13485 standard.
  • Definition of QC test specifications.
  • Product development and improvement.
  • Monitoring of deadlines.
  • Regulatory watch: FDA, Health Canada…
  • Multi-disciplinary collaboration.
Technical Support

Technical support requires a good knowledge how medical devices are used. Through this service, we help professionals to troubleshoot application bugs and to maintain and upgrade their medical devices.

  • Maintenance support of medical devices.
  • Management of the ISO 13485 standard.
  • Incident resolution.
  • Document review: SOPs, protocols…
  • Collaboration on software development.
  • Regulatory watch: FDA, Health Canada…
  • Staff training.
  • Multi-disciplinary collaboration.

Quality & Regulation

Quality Assurance

In the medical devices industry, our consultants support our customers in quality assurance, whether it is to meet their needs, ensure compliance with quality standards or improve their reputation.

  • Management of quality assurance projects.
  • Management of the ISO 13485 standard.
  • Document review: SOPs, protocols…
  • Drafting of the quality manual and APQR reviews.
  • Complaint management and definition of KPIs.
  • Drafting of deviations, CAPA, change control.
  • Quality investigations: Ishikawa, etc.
  • Staff training on procedures.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…
  • Multi-disciplinary collaboration.
Regulatory Affairs

We understand very well the variety and complexity of medical devices: surgical instruments, prostheses, electronic devices, implants, injectables… We thus effectively monitor the regulations in this sector in order to provide a relevant support to our customers.

  • Regulatory management of medical devices projects.
  • Drafting and review of regulatory documents.
  • Documents submission for marketing authorization.
  • Audit and drafting of SOPs related to regulations.
  • Staff training on procedures and risks.
  • Regulatory watch: FDA, Health Canada, ISO 13485…
  • Multi-disciplinary collaboration.