Comprehensive medical device consulting for regulatory success and market excellence

Tailored to your needs

Valicare’s team of medical device consultants is dedicated to guiding manufacturers through regulatory complexities and helping them achieve compliance with standards like EN ISO 13485, EN ISO 14971, ISO 10993 family, and IEC 62366. With our support, your products will meet the highest quality, safety, and usability requirements for successful market entry and lifecycle management.

To ensure patient safety and product efficacy, regulatory authorities like the EU MDR and FDA require compliance with several key standards. We offer comprehensive support to integrate these standards into your quality and compliance framework.

Our customer-orientated approach is designed to develop customized solutions that not only ensure product safety and regulatory compliance, but also promote innovation and efficiency. With this end-to-end support, we create the basis for the successful development and marketing of your medical devices.

Our services tailored to your needs:

• Regulatory compliance support
  Navigate complex regulations confidently with our expertise, ensuring compliance with MDR ((EU) 2017/745), the FDA (21 CFRs), and other global requirements to streamline your market entry and regulatory audits.
• Quality management system (QMS) development
  We assist in building and maintaining robust QMS frameworks tailored to EN ISO 13485 requirements, focusing on product safety, risk management, and continuous quality improvement.
• Risk management (EN ISO 14971)
  Our risk management services are grounded in EN ISO 14971, offering structured risk assessments throughout the product lifecycle to identify, evaluate, and mitigate potential risks, ensuring a proactive approach to patient safety.
• Usability engineering (IEC 62366)
  With Valicare’s usability engineering expertise, we ensure your devices are user-friendly, reducing errors and optimizing patient safety. Our process includes human factors analysis, usability testing, and regulatory compliance guidance, all designed to improve device functionality and regulatory acceptance.
• Biocompatibility assessment (ISO 10993 family)
  Valicare’s biocompatibility assessments, based on ISO 10993 and MDR requirements, evaluate your devices materials' compatibility with human tissue, critical to meeting regulatory expectations and ensuring product safety for patient use.
• Process validation and qualification
  Our team conducts comprehensive process validations and equipment qualifications to ensure your production processes consistently deliver high-quality, compliant products.
• Supplier management
  We offer complete supplier evaluation, monitoring, and compliance support to help you build and maintain a reliable and fully compliant supply chain.
• Training and education
  Empower your team with our training programs, covering GMP, quality management principles, and regulatory updates tailored to your companies’ unique needs.