Medical Devices

Compliance for a safer tomorrow.

We support medical device manufacturers
with validation services that meet FDA
and global regulatory expectations.

  • Quality
    Systems    Quality SystemsValidation of electronic quality management platforms for CAPA, complaints, change control, audits and document control.
  • Design &
    Development    Design & DevelopmentCompliance support for design controls, requirements traceability and software development under ISO 13485 and IEC 62304.
  • Manufacturing
    Systems    Manufacturing SystemsValidation of the ERP, MES and production-equipment software used to build and release medical devices.
  • Post-Market
    Systems    Post-Market SystemsValidation of complaint-handling, vigilance and field-surveillance systems that monitor devices after release.

Compliance
is not a destination,
it’s a process.

  • QUALITY
  • INTEGRITY
  • INNOVATION
  • TRUST