CMDCAS

AcronymDefinition
CMDCASCanadian Medical Devices Conformity Assessment System
References in periodicals archive ?
With the transition from CMDCAS to MDSAP already underway in Canada, manufacturers who already market medical devices in Canada, and/or Australia, Brazil, Japan, and the USA, should now assess their readiness for the introduction of MDSAP.
mdi's services include: 510(k) preparation and assistance (we have successfully obtained over 1600 510(k) clearances), FDA strategic planning, assisting in dealing with FDA inspections, 483 and W/L responses, Corrective and Preventive Actions, FDA liaison, conducting mock FDA QSR audits, clinical trials, on-site training for all aspects of the FDA and ISO, ISO13485 assistance, setting up and getting ISO certification, Technical File preparation for the CE mark, CMDCAS filings for Canada CE mark.
The CTLM([R]) system has received international certifications and licenses including: CE Marking, CMDCAS Health Canada, UL listing, ISO 13485 certification, China SFDA, ANVISA, EC-full quality assurance certificate and FDA export certification.
Certifications: FDA Registered; ISO 13485:2012 certified; 510(k) and PMA device experience; CMDCAS (Canada) certified; Japan & Australia accreditation as Foreign Manufacturer; Brazilian Approved Devices; ISO 9001:2008 certified offshore facilities with identical equipment; Manufactured according to Directive 93/42/EEC
The ISO 13485 standard “Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes” provides the base model for a medical device company's quality system; it also complies with the European Union medical device directives for CE marking, Health Canada CMDCAS, and other international requirements.
The CTLM system has received certification and licenses to sell internationally European CE marking, CMDCAS Canadian License, China SFDA, ISO 13485:2003, EC-full quality assurance certificate and FDA export certification.
ASI complies with international quality standards including ISO, CE, CMDCAS and 21CFR part 820.
Robling is FDA registered, and compliant with ISO 13485 & 9001 21 CFR part 820, CMDCAS, & JPAL.
mdi's services include: 510(k) preparation and assistance (we have successfully obtained over 1100 510(k) applications), FDA strategic planning, assisting in dealing with FDA inspections, 483 and W/L responses, Corrective and Preventive Actions, FDA liaison, conducting mock FDA QSR audits, clinical trials, on-site training for all aspects of the FDA and ISO, ISO13485 assistance, setting up and getting ISO certification, Technical File preparation for the CE mark, CMDCAS filings for Canada CE mark.
In order to create a safe treatment for patients, Foremount use medical grade material and comply with ISO 13485 standard as well as conforming to CE, FDA and CMDCAS regulations.
All Foremount's products are manufactured to meet the requirement of ISO standard and conform to ISO 13485, CE, FDA and CMDCAS regulation.
The CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.