CMDCAS

AcronymDefinition
CMDCASCanadian Medical Devices Conformity Assessment System
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References in periodicals archive ?
About five AOs are currently handling nearly 90 percent of all CMDCAS certifications--not nearly enough to meet the demand created by the Canadian MDSAP mandate.
His responsibilities include the program development and technical expertise for UL's medical regulatory programs including FDA 510(k) and inspection programs, CMDCAS (Canada) and European MDD, and IVDD Notified Bodies.
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, ISOl 3485 assistance, setting up and getting ISO certification, Technical File preparation for the CE mark, CMDCAS filings for Canada CE mark.
CAN/CSA-ISO 13485 assessments and certification must be performed by Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars.
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 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.
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
ASI complies with international quality standards including ISO, CE, CMDCAS and 21CFR part 820.
ASI complies with the highest 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.