Medical Devices

Market approval processes including EU MDR – CE certifications, US FDA clinical trial and US device approvals. Implementation of ISO 13485 quality management systems. Particular expertise in high risk combination devices requiring specific regulatory procedures involving animal/ blood/ tissue and drug components.
We manage and lead your product development program

Services in the area of quality and regulatory affairs covering the devices under the MDR and 21CFR including device drug and device tissue combination products.

Regulatory Strategy and Due Diligence
  • Strategic regulatory road map from product development to product approval
  • Strategic road map combining regulatory and commercial aspects to facilitate new funding
  • Strategies to accelerated approvals (FDA EFS, Breakthrough, e.g.)
  • Gap assessments RA/QA
  • Clinical evaluation / PMS/PMCF expertise
  • Assistance with additional procedures for conformity assessment (such as Annex IX section 5)

Quality from R & D to the market-place: Your partner in defining strategies on Quality System implementation and maintenance.

Signifix has expertise and can provide consultancy services in the following areas:

  • Quality system strategies to meet regulatory and quality requirements
  • ISO/GLP/GMP quality management systems
    • 21CFR 820
    • 2017/745MDR EU Medical Device Regulations
    • ISO 13485:2016
  • Management of quality system certification and inspection processes, including coordination of audits & inspections by regulatory authorities
  • Risk management processes (ISO 14971)
  • Interim management of QA/QC
  • Gap analyses, to identify improvement measures for compliance or to improve the efficiency of business processes
  • Internal and vendor audits (domestic and international)
  • Trouble shooting, effective & efficient problem solving
  • Training and coaching, customized training programmes for individuals and groups
Specific Projects
  • Multiple regulatory strategies, approvals and support for a diverse spectrum of Medical Devices (e.g. cardiovascular and orthopedic implants, neurology and dermal/ plastic surgical devices, blood and animal derived devices)
  • Regulatory approvals of E-Health applications (e.g. medical apps, web-based systems)
  • Multiple regulatory strategies and approvals and support in combination products (e.g drug eluting stents, devices containing human plasma derived components)
  • Quality Management Systems certifications (ISO 13485)
  • MDR gap analyses and implementations
  • Regulatory Affairs projects
    • Pre-IDE, IDE, SubQ, 510(k), PMA, HDE/ accelerated routes, CE, MDR eg
    • Scientific Advice for drug device combination products
  • Leading critical phases in product development