We can be your dedicated guide who understands the language of regulators to steer your mission to success. We offer a unique blend of scientific precision, business acumen, and multilingual communication skills. Whether it’s maneuvering through complex regulatory landscapes, optimizing post-market surveillance, or leading successful audits, we're here to elevate your business above the noise and confusion.

Our Specialty

  • CE Marking

  • Clinical Trial Applications

  • Quality Management System

  • Risk Management

CE Marking

  • Developing technical documentation structure for submission to notified body in compliance with EU MDR
  • Authoring technical documents
  • Advising on strategic interactions with notified body and MDD to MDR transition

Clinical Trial Applications

  • Developing documentation structure for clinical trial submissions in EU, Switzerland, and Canada in compliance with ISO 14155
  • Preparing US IDE
  • Advising and developing response strategies to regulatory authority feedback

Quality Management System

  • Developing new QMS
  • Auditing existing QMS for ISO 13485 and EU MDR compliance
  • Reviewing and developing SOPs for compliance with ISO 13485 and EU MDR

Risk Management

  • Developing risk management process for compliance with ISO 14971
  • Preparing risk management file
  • Training personnel
Let Our Experience Be Your Guide