Medical Devices compliance management
ISO 13485 Compliance Made Simple
Our Medical Device Compliance services ensure that your organization meets ISO 13485 standards, fostering safety, reliability, and global market approval.
Our Services Include:
Gap Analysis and Compliance Assessment:
Evaluate your QMS against ISO 13485 standards and address non-compliance with actionable recommendations.
QMS Development & Implementation:
Develop documentation, procedures, and records to support compliance and efficiency.
Regulatory Documentation Support:
Prepare and review technical files and ensure alignment with ISO 13485, FDA, MDR (EU), and MDSAP requirements.
Internal & Supplier Audits:
Ensure compliance within your organization and across your supply chain.
Risk Management Integration:
Implement ISO 14971-aligned risk management processes to ensure product safety.
Why Choose Us?
With our expert guidance, you can streamline compliance, enhance quality, and build a reputation for excellence in medical devices.
We are committed to the success of your products and to help you develop and implement regulatory and quality solutions catered to your needs.
Our team of consultants bring many years of combined experience in Regulatory Affairs, Compliance and Quality Assurance, working with regulatory bodies around the world such as the TGA, Medsafe, FDA, EU Competent Authorities and Notified Bodies, and various global Authorized Representatives with a proven track record of executing techniques in a timely and cost efficient manner.
