Our Commitment to Quality & Compliance
Paradigm Spine is committed to the highest standards of patient safety, product quality, and regulatory compliance. This page provides access to our key Quality Management System certificates and selected official confirmation letters for major regulatory milestones — including the transition of certain devices from the Medical Device Directive (93/42/EEC) to the Medical Device Regulation (EU) 2017/745.
Please note that not all internal approvals and detailed regulatory files are published here. If you require additional documentation for regulatory submissions or other compliance needs, please contact us directly via email at psg-service@paradigmspine.com.
Quality Management System Certificates
Our current certificates demonstrate compliance with recognized international standards for medical device design, production, and quality control.
Available Certificates:
- ISO 13485 Certificate — Quality Management System for Medical Devices.
- MDSAP Certificate — Medical Device Single Audit Program (MDSAP) compliance covering multiple participating regulatory authorities (e.g., FDA, Health Canada, TGA, ANVISA).
- MDD Certificate — Certificates issued under the Medical Device Directive (93/42/EEC) for legacy devices maintained during the transition to the Medical Device Regulation (EU) 2017/745 (MDR). MDR Certificate(s)
- MDR Certificate(s) — For devices that have been fully transferred under the new EU Regulation 2017/745.
MDR Transition Confirmation
- Paradigm Spine is actively transitioning its legacy medical devices from compliance under the Medical Device Directive (MDD) 93/42/EEC to the Medical Device Regulation (MDR) (EU) 2017/745. Confirmation letters issued by our Notified Body demonstrate the ongoing process of this transition. Please find the official confirmation letters for these transfers below for your reference.
- Confirmation Letter – Device classification III & IIb implantable
- Confirmation Letter – Device classification IIa & IIb
Need More Information?
We understand that some customers or partners may require specific documentation for local registrations, tenders, or audits.
If you need further details about a certificate, device registration, or other regulatory documentation, please contact our Customer Service team via E-Mail at psg-service@paradigmspine.com.
We are happy to assist.
Note: Some documents are confidential and may not be publicly available on this website. We will handle all requests according to applicable data privacy and regulatory requirements.