Consulting Services

When Precision Matters, Healthcare Professionals & Manfacturers Trust Filos Health Laboratory

At Filos Health Laboratory, we specialize in providing expert guidance for medical device and lab testing compliance. From regulatory strategies to advanced diagnostic solutions, our team of experienced scientists, medical practitioners, and compliance consultants understands the intricacies of the healthcare industry. With hands-on expertise in biological safety, QA/RA, and cutting-edge diagnostics, we ensure your products meet global regulatory standards. Leveraging insights from thousands of tests and clinical studies annually, our team delivers informed solutions tailored to meet the expectations of regulators like the US FDA, European Notified Bodies, and beyond.

WE CAN HELP YOU IN THE FOLLOWING AREAS

1. US FDA Consulting for Medical Devices and IVDs

Comprehensive Expertise in FDA Compliance
Whether you’re introducing a new medical device in the U.S. or ensuring compliance for an existing one, Filos Health Laboratory offers expert guidance to navigate the complexities of FDA regulations. Unlike conventional consultancies, our regulatory experts collaborate with a team of preclinical and clinical specialists, providing deep insights into what FDA reviewers expect. Combining institutional knowledge with real-world experience, we deliver tailored solutions to help you achieve and maintain compliance with confidence.

Filos Health Laboratory provides expert guidance to navigate the complex FDA medical device and IVD regulations, ensuring full compliance with all requirements. Our services include:

  • FDA Regulatory Strategy & Compliance
  • FDA 510(k) Clearance Consulting
  • FDA Investigational Device Exemption (IDE)
  • FDA Premarket Approval (PMA) & Submission
  • FDA Pre-Submission Consultation

2. EU MDR & IVDR Regulatory Consulting

Extensive Expertise in European CE Marking Compliance for Medical Devices and IVDs
Whether you’re launching a new medical device in Europe or transitioning a legacy device under the EU Medical Device Regulation, Filos Health Laboratory’s global regulatory team is here to guide you through the complex regulatory process. With deep clinical expertise across diverse therapeutic areas, we understand exactly what European regulators expect. By combining institutional knowledge with hands-on industry experience, our consultants ensure your devices meet and maintain CE marking compliance with confidence.

Filos Health Laboratory offers comprehensive support to meet the rigorous requirements of EU medical device and IVD regulations. Our services include:

  • EU Post-Market Surveillance (PMS)
  • IVD Performance Evaluation Plans and Reports
  • Clinical Evaluation Plan and Report Writing
  • Summary of Safety and Clinical Performance
  • EU MDR and IVDR Technical Documentation
  • PMCF Plans, Surveys, and Reports
  • IVD PMPF Plans, Surveys, and Reports
  • Periodic Safety Update Reports (PSUR)

3. Global Regulatory Affairs & Quality Assurance Consulting for Medical Device & IVD Manufacturers

Premarket Strategy to Postmarket Support
Filos Health Laboratory assists medical device and IVD manufacturers at every stage, from preclinical studies and clinical research to testing new innovations and existing devices. With extensive experience across various device types, we offer a comprehensive understanding of regulatory expectations. Our team of regulatory and quality management system consultants is dedicated to helping you navigate and comply with US FDA, EU, and other international regulatory requirements.

Filos Health Laboratory provides expert guidance to navigate the RA/QA strategy, ensuring full compliance with all requirements. Our services include:

RA/QA Strategy and Compliance

  • QA/RA Outsourcing
  • Regulatory Consulting for Borderline & Combination Devices
  • Systematic Literature Search & Reviews (FDA & MDR)
  • Quality Management System Implementation & Support
  • ISO 13485 & FDA Mock Audits
  • Medical Device Single Audit Program (MDSAP) Compliance
  • ISO 14971 Risk Management Consulting
  • Regulatory Remediation Consulting
  • Clinical & Regulatory Strategy
  • AI, ML, & Software as a Medical Device (SaMD) Regulatory Support

Let's Talk About Your Project

Reach out with any questions or request a meeting with a Filos Health Laboratory expert to discuss your specific project. We’ll respond promptly. 

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