Adept’s own VP of Client Solutions and subject matter expert, Jan Gates, recently penned an informative article for MD+DI outlining the most important questions medical device packaging professionals must ask themselves to determine if they are ready for compliance. You can find “6 Questions to Ask Yourself about ISO 11607 Compliance” here.
Every terminally sterilized medical device company has to deal with over 115 FDA and EU packaging requirements to stay compliant and prepare for FDA or EU inspections. The process of monitoring and documenting compliance to ensure packaging tests correctly and will receive clearance can be a daunting task. The ISO 11607-1/-2 experts at Adept Packaging have developed a simple solution to guarantee inspection success both now and in 2019 when revisions to the guidelines are expected to be released.
This proprietary, thorough checklist allows Adept experts to determine exactly what a company is doing right, as well as where they need to improve, accompanied by actionable steps for compliance. Adept will also reach out to specific consultants if needed to gain additional insight in order to get issues resolved quickly, efficiently and cost-effectively.
Adept’s ISO 11607 audit team includes industry experts focused on keeping our clients on top of changing regulations and documentation requirements. We see past the current requirements with insider information on tomorrow’s compliance procedures, including the upcoming addition of human factor regulations.
Contact a specialist today to learn more about how your organization can benefit from the ISO 11607 Audit Readiness Program.