Regulatory Pathway Consulting
Consulting for
European Market (EU MDR 2017/745)
We provide expert guidance to medical device manufacturers navigating the EU MDR regulatory pathway. Our services include:
- Pathway strategy: providing the regulatory pathway of market access based on classification of medical device including stages of compliance, applicable standards, required pre-clinical studies and technical documentation, required clinical studies (evaluation/ or Trial/ Literature review, etc.), Certification pathway and registration of medical device.
- Gap Analysis: Assessing compliance with MDR requirements and identifying areas needing improvement.
- Technical Documentation Support: Assisting in the preparation and review of comprehensive technical files and clinical evaluations.
- Quality Management System (QMS): Ensuring alignment with MDR and ISO 13485 standards.
- Notified Body Interaction: Supporting submissions, addressing feedback, and facilitating smooth approval processes.
- Post-Market Surveillance: Implementing robust systems to meet MDR vigilance and reporting requirements.
With deep expertise and personalized strategies, we help streamline your journey to MDR compliance, ensuring market readiness and regulatory success.
Consulting for
USA Market (US FDA)
We assist medical device manufacturers in successfully navigating the US FDA regulatory pathway by providing:
- Regulatory Strategy Development: Crafting tailored strategies to determine the optimal classification and submission route (510(k), De Novo, PMA).
- Pre-Submission Support: Guiding you through FDA Q-Sub meetings to gain clarity and alignment on regulatory expectations.
- Submission Preparation: Developing and reviewing comprehensive 510(k), PMA, and De Novo applications to ensure compliance with FDA requirements.
- Quality System Compliance: Aligning your QMS with FDA's 21 CFR Part 820 regulations.
- Post-Market Requirements: Supporting adverse event reporting, recalls, and continuous compliance to FDA guidelines.
Our expertise ensures a clear, efficient pathway to FDA market approval, helping you achieve compliance with confidence.
Consulting for
Australia Market (TGA)
We support medical device manufacturers through the TGA regulatory registration pathway with tailored services, including:
- Device Classification: Determining the correct classification of your medical device based on TGA's framework to identify applicable requirements.
- Pathway strategy: providing the regulatory pathway of market access based on classification of medical device including stages of compliance, applicable standards, required pre-clinical studies and technical documentation, required clinical studies (evaluation/ or Trial/ Literature review, etc.), Certification pathway and registration of medical device. or Other Alternatives such as CE Certification, FDA approval for market access
- Conformity Assessment Evidence: Assisting in obtaining or leveraging existing certifications (e.g., CE Marking or FDA approvals) to meet TGA conformity requirements.
- ARTG Registration: Preparing and submitting comprehensive applications for inclusion in the Australian Register of Therapeutic Goods (ARTG).
- Technical Documentation Compliance: Ensuring technical files and evidence meet TGA's stringent safety, efficacy, and performance standards.
- Sponsor Collaboration: Supporting collaboration with your Australian sponsor to streamline the registration process.
With our expertise, manufacturers can confidently achieve TGA compliance, ensuring seamless market entry into Australia.