Is your company currently ISO 9001 compliant or certified and in need of help implementing the ISO 13485 medical device manufacturing standard? Oxebridge can help.
Oxebridge can implement ISO 13485 using Oxebridge’s proprietary “Rapid Implementation” methods, getting your system in place in only a few weeks. In most cases, we can include the requirements for CE Marking under the medical device directive, as well as the FDA’s GMP requirements and the Canadian Medical Device Regulations (CMDR), all in one effort.
How is this possible? By not reinventing the wheel, and only focusing on the requirements of ISO 13485, while handling all the documentation updating and rewriting so your staff do not need to. A typical ISO 13485 upgrade process follows a few simple steps:
- We review your current system documentation and processes
- We interview your staff to see where you already comply with ISO 13485 and, if desired, CE Marking, FDA GMP and CMDR
- We update your documentation and submit the revised documents to your staff for review and approval
- We train your employees on the changes
- We train your internal auditors using a customized internal auditor training program, designed specifically for your company
- We conduct a round of ISO 13485 internal audits, with your internal auditors acting as “shadow” auditors for additional training purposes
- We help conduct an ISO 13485 compliant Management Review.
As with all Oxebridge programs, the resulting systems and documentation are completely custom to your organization, and not boilerplate-based.
For more on ISO 13485, click here.
Please note that companies seeking ISO 13485 upgrade services must have a current ISO 9001 or orther QMS certificate, provided by an accredited registrar, or additional services (and costs) may be required.