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