Grant Ramaley is Director of Regulatory Affairs for Aseptico Inc., a manufacturer and marketer of dental support equipment in the United States and Canada since 1975. Ramaley is co-chairman of the Regulatory Affairs and Standards Committee for the Dental Trade Alliance, Convener for the ISO 13485 Working Group at the International Accreditation Forum, and Technical Committee Advisor to the Asian Harmonization Working Party. Grant is well versed in ISO and Quality Assurance practices for the medical device community.
Navigating New ISO 13485 Quality Assurance and EU Device Regulations
Must Know: ISO 13485 Changes
Recently, 20 DTA member companies participated in the DTA regulatory webinar, Navigating New ISO 13485 Quality Assurance and EU Device Regulations to understand the changes made to ISO 13485, which defines quality assurance of medical devices. The attendees came away with valuable information about how to address the important changes being made, including:
- Companies must pay more attention to software instructions that come with the device.
- Manufacturers must include the Unique Device Identification (UDI) as part of their overall design and for traceability.
- Manufacturers must provide clear sterilization information and instructions as part of their finished device. (Prepare for the EU to implement UDI in the coming years.)
- Overall more regulatory compliance issues and more focus on managing risk.
- Companies must maintain and produce records for the roles of the individual employees involved in regulatory affairs including job titles, procedures and more to be compliant under the new ISO 13485 rules.
In addition, attendees learned detailed information regarding the new ISO 13485 Quality Assurance that manufacturers need to make it possible to sell their dental devices in the U.S., the European Union and across the world. The webinar showed how small changes to the ISO can have an impact on having devices approved by notified bodies to sell in various countries.
This webinar is one of many that DTA hosts to help members stay up to date on information that affects their companies. Click here to see the list of available webinar replays.