SeerPharma has assisted an Australian 3D Printing Medical Device company to develop an ISO 13485 compliant Quality Management System (QMS).
The company plans to make orthopaedic implants using 3D printing technology. These devices will be custom made for named patients. The device will be provided cleaned, but not sterilised. The medical device manufacturer requested that SeerPharma provide assistance to design and implement a Quality Management System that meets ISO 13485 requirements.
SeerPharma has designed and developed relevant Quality System documentation. The manufacturer requested that we train their staff every step of the way, ensuring they understand the requirements of the system and how it is implemented.
To execute such a project, SeerPharma:
- Prepared a project plan identifying responsibilities and time lines.
- Prepared material and component specifications and a Device Master Record.
- Prepared a Quality Manual.
- Established a Design History File
- Facilitated Risk Assessments.
- Prepared all appropriate documentation relating to the qualification of the facility and the equipment.
- Qualified all software and hardware as appropriate for off the shelf systems.
- Trained and coached all relevant staff in the requirements of ISO 13485 and their Quality System.
- Prepared all necessary regulatory documentation required by the TGA.
SeerPharma has expertise in the Quality Compliance inter-relationships needed to achieve business goals, compliance to the TGA regulations, and the development and implementation of ISO 13485 compliant processes. We helped prepare the documentation needed for Conformity Assessment applications. SeerPharma has assisted a number of device companies with the implementation of Quality Systems and in gaining regulatory compliance and licensing for a range of medical devices.
Contact us if you’re a Medical Device manufacturer looking to set up or review your Quality Management System to ensure that it is compliant to ISO 13485.
This post comes from our July 2015 Journal.
