June 26, 2017
Commercial Commitment
I, the undersigned: …..………………………………………………………………...………………………….
Acting on behalf of (company): ………...………………………………………………………………………..
As (capacity or position): ……………………………………..……………………….………………………….
Hereby acknowledge having taken note of thepolicy followed by LNE/G-MED regarding thetransition fromISO 13485 within CMDCAS program certification to the ISO 13485 MDSAPcertification.
Consequently, I expressly inform LNE/G-MEDof the decision made by the company I represent regarding its current application to LNE for the ISO 13485 within CMDCAS program certification andthe transition to the ISO 13485 MDSAP certification, as per the corresponding option it retains as duly checked below:
Option 1
The company hereby commits itself to having the MDSAP initial audit performed. The company wishes to have it performed during the month and year of ………………………………………………… and prior to August 31st, 2018.While awaiting to receive from LNE/G-MEDthe offer with full quotation of certification services specifically related to its own requirements, the company has been informed that the duration for a MDSAP initial audit is typically estimated to a 6.5 man-day duration in the case of a manufacturer with one site, and one category of medical device on the market for one of the 5 countries covered by the MDSAP(or a corresponding estimated amount of $ 21,800). The duration would be estimated to 16 man-day duration in the case of a manufacturer with one site, 4 categories of medical device on the market and 5 applicable country regulations (or a corresponding estimated amount of $ 44,000).
Note 1: Upon receipt of the completed client information form (questionnaire), LNE/G-MED will confirm with the company whether the auditperformance is feasible at the requested period of time and send to the company the related offer with full quotation of certification servicesspecifically related to the company’s requirements.
Note 2: If the company does not accept the above mentioned offer with full quotation by the end of the period of validity of said offer, the company is aware that it will not be included as a priority in the initial audit planning. An adjustment fee of $6,000 will be applied to the alternative offer that will be sent to the company.
Option 2
The company wishes to terminate the ISO 13485 within CMDCAS program certification as of today. Accordingly, the corresponding ISO 13485 within CMDCAS certificate will be immediately withdrawn and Health Canada will be duly informed of such withdrawal by LNE/G-MED as required.
Option 3
The company does not wish to carry out a transition to ISO 13485 MDSAP certification but would like to have the period of validity of its current ISO 13485 within CMDCAScertificate maintained until December 31st, 2018. Accordingly, as per Health Canada’spublished decision, the corresponding medical device license(s) based on suchISO 13485 within CMDCAS certificate will not be maintained beyond such date. The company hereby expressively authorizes LNE/G-MEDnot to include the company within its planning for upcoming MDSAP audits in 2017 and 2018.
On (date): ……………………………………...…….……………………….
At (location): ………………………………………………………….………
For (name of company)By (name of representative)
Signature
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