CMDCAS ISO 13485 Guaranteed Certification and Online Training Courses :,ISO 13485, MEDICAL DEVICES FDA/CGMP FDA/CGMP FOOD FDA/CGMP.

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100% Success Rate

60-90 days*

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Frequently Asked Questions about CMDCAS

Key Steps for CMDCAS Certification

Online Training Link (Quality University)

What is CMDCAS?

CMDCAS is a requirement established by Health Canada that applies to the manufacture and sale of medical devices (class II, III, and IV).

Who needs to get CMDCAS certified?

Manufacturers selling class II, III and IV devices in Canada must be registered to ISO 13485/ISO 13488 by a quality systems registrar accredited under the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS).

What are the requirements for registration of quality management systems for devices to be licensed by Health Canada?

The requirements are as follows:

· Class II manufacturers must be registered to at least ISO 13485:2003 by a CMDCAS accredited registrar,

· Class III and IV manufacturers must be registered to ISO 13485:2003 by a CMDCAS accredited registrar,

· Since 1 January 2003 all manufacturers of class II, III and IV devices are required to have been assessed by a CMDCAS accredited Registrar.

What are the benefits of achieving CMDCAS certification?

The company will be able to meet Health Canada requirements.

What is the time duration required for a company to achieve CMDCAS certification?

CMDCAS certification can be achieved in as little as 90 days depending upon the company commitment.

What are the certification steps?

Please visit http://accelcert.com/cmdcas.html for the steps to certification.

Where can I get help with consulting?

Please visit http://www.accelcert.com for assistance with consulting.

Where can I get help to achieve CMDCAS certification with a written guarantee?

ISO Accelerate Group offers written guarantee certification services with the condition your company will comply with recommendations.

Where can I get training for CMDCAS?

ISO Accelerate Group offers online, onsite, and customized training. Please visit http://www.accelcert.com for more information.

Where can I get online training and certification?

Quality University provides online training and certification. For more information, follow this link: http://www.qualityuniversity.com

My company is ISO 9001 and/or ISO 13485 certified. Where can I get help to upgrade to CMDCAS?

Please visit http://www.accelcert.com for more information.

Where can I get free cost information for CMDCAS consulting?

Please contact Accelcert at 1-888-476-9103 for specific quotes.

Where can I get free cost information for CMDCAS certification?

Please contact Accelcert at 1-888-476-9103 for specific quotes.

Where can I get a free audit checklist for CMDCAS?

Please contact Accelcert at 1-888-476-9103 for specific quotes.

*The above information is provided for the better understanding of the specific standard, certification process, consulting, and training resources. We do recommend that you or your company should refer to the latest standards and verify information and/or contact the resources listed, or as applicable.

Step 1 Prepare CMDCAS Implementation Plan and Detailed Schedule Accelerate & Clients ACCELERATE	+ Prepare plan for the CMDCAS Quality System Development (Accelerate will work with Client)
Step 2 CMDCAS Gap Assessment ACCELERATE	+ Perform the CMDCAS Gap Assessment to Identify GAPS between the standard and what exist. (Accelerate will prepare the report)
Step 3 CMDCAS Training (Auditors) ACCELERATE	+ Train the CMDCAS Internal Auditors and Process Owners to the Standard. Upon passing the exam, process owner taking training will get qualified as Internal Auditor and Lead Auditor Accelerate will issue certificate.
Step 4 CMDCAS Implementation Training ACCELERATE	+ Train process owners to CMDCAS Implementation Process. (Accelerate will perform the activity) ISO will issue certificate on passing exam.
Step 5 CMDCAS Quality Policy (Define & Document) Accelerate & Client ACCELERATE	+ Define CMDCAS Quality Policy to internal and external customers. (Accelerate will prepare Quality Policy working with Client
Step 6 CMDCAS Quality Objectives (Define & Document) Accelerate & Client ACCELERATE	+ Define CMDCAS Quality Objective with reference to Quality Policy. (Accelerate will prepare working with Client)
Step 7 CMDCAS Measurement Analysis & Improvement (Define & Document) ACCELERATE	+ Define CMDCAS Measurement Analysis Process for continuous improvement. (Accelerate will prepare working with Client)
Step 8 CMDCAS Quality Planning (Define & Document) ACCELERATE	+ Define CMDCAS Quality Planning Process. (Accelerate will prepare working with Client)
Step 9 CMDCAS Executive Management Training ACCELERATE	+ Train CMDCAS Executive Management for the process for Conducting Management Review. (Accelerate will issue certificate)
Step 10 CMDCAS Documentation of Data Control -Development of a consistent approval process ACCELERATE	+ Define CMDCAS Documentation and Data Control Process for development and Management of Documentation Control System. (Accelerate will develop, works with Client, which include infrastructure for Documentation Control)
Step 11 CMDCAS Level I (Quality Manual) ACCELERATE	+ Prepare CMDCAS Quality Manual. Document the Company Policy in the manual for compliance to the standard. (Accelerate will prepare for Client)
Step 12 CMDCAS Level II (Standard Operating Procedures) ACCELERATE	+ Define the process and the interaction between the CMDCAS processes. Document each process in compliance with the standard. (Accelerate will prepare with Client)
Step 13 CMDCAS Level III (Work Instructions) Draft Accelerate & Client ACCELERATE	+ Document the CMDCAS processes in detail if needed. (Accelerate will work with Client)
Step 14 CMDCAS Level I (Quality Manual) Approval/Sign-Off Client ACCELERATE	+ Have Top Management sign the CMDCAS Quality Manual. (Client works with Accelerate)
Step 15 CMDCAS Level II (SOP) Approval/Sign-Off Client & Accelerate ACCELERATE	+ Have all CMDCAS procedures approved by process owners and concerned functions. (Client works with Accelerate)
Step 16 CMDCAS Level III (Work Instructions) Approval/Sign-Off Client & Accelerate ACCELERATE	+ Have work instruction signed-off by concerned functions. (Client works with Accelerate)
Step 17 CMDCAS First Internal Audit (by qualified Internal Auditors) Client & Accelerate ACCELERATE	+ Perform CMDCAS first Internal Audit. This audit will be conducted by independent Internal Certified Auditors. (Client will perform with support from Accelerate)
Step 18 CMDCAS Corrective & Preventive Actions, customer, vendor, quality Client & Accelerate ACCELERATE	+ Do close loop CMDCAS corrective and preventive action for all issues including issues from Internal Audit (STEP 17). (Client will perform with Accelerate)
Step 19 CMDCAS First Management Review (Performed by Management Rep. & Executive Mgmt.) ACCELERATE	+ Conduct Management Review as per CMDCAS Management Review procedures. (Client works with Accelerate)
Step 20 CMDCAS Second Internal Audit (By Qualified Internal Auditors) Accelerate & Client ACCELERATE	+ Perform CMDCAS second Internal by Certified Internal Auditors (same as STEP 17). (Client works with Accelerate)
Step 21 CMDCAS Corrective & Preventive Action for 2nd Internal Audit Accelerate & Client ACCELERATE	+ Perform close loop CMDCAS corrective and preventive action (Same as STEP 18). (Client works with Accelerate)
Step 22 CMDCAS Second Management Review (By Executive Mgmt.) Client & Accelerate ACCELERATE	+ Perform CMDCAS Management Review as per Management Review Procedure (same as STEP 19). (Client works with Accelerate)
Step 23 CMDCAS Registrar Pre-Assessment (Optional Activity) Registrar Client & Accelerate ACCELERATE	+ CMDCAS Registrar (an independent certifying body) to perform Pre-Assessment (Accelerate will support)
Step 24 CMDCAS Corrective & Preventive Actions to registrar finding Accelerate & Client ACCELERATE	+ Do close loop CMDCAS corrective actions (same as STEP 18 & 21) (Client works with Accelerate)
Step 25 Accelerate CMDCAS Documentation Review ACCELERATE	+ Accelerate Review the complete system for compliance to standard.
Step 26 Accelerate Assessment for CMDCAS ACCELERATE	+ Accelerate perform CMDCAS audit for identifying issues to related Implementation.
Step 27 CMDCAS Corrective & Preventive Actions ACCELERATE	+ Do close loop CMDCAS corrective & preventive action for all issues raised (STEP 25 & 26)(Accelerate works with Client)
Step 28 CMDCAS Final Registration Audit ACCELERATE	+ Registrar perform the CMDCAS final Registration Audit. (Accelerate will support)
Step 29 Prepare action plan for CMDCAS registrar finding ACCELERATE	+ Submit CMDCAS Action Plan & close Registrar Findings. (Accelerate works with Client)
Step 30 Client Certified ACCELERATE	+ Accelerate Registered Client in Accelerate Database as "Certified"
Step 31 Maintaining Upgrade & Training for CMDCAS ACCELERATE	+ Accelerate will provide. (If desired)

ISO 13485: Internal Auditing /Auditor and Implementation

ISO 13485 Executive Management Review meeting ISO 13485

ISO 13485: Introduction & Awareness for meeting ISO 13485 requirements

ISO 13485 Internal Auditing/Auditor and Implementation in Chinese

RISK Management Employee Overview for Medical Device meeting ISO 14971/ISO 13485/FDA/CE MARK

CE Marking (90/385) for Active Implantable Medical Devices- Essential Requirements Only

CE Marking (90/385) for Active Implantable Medical Devices- Implementation and Auditing

CE Marking (93/42 ECC) for medical devices- Implementation and Auditing

CE Marking (93/42 ECC) for medical devices- Essential Requirements only

CE Marking IVD 98-79 EEC Implementation and Auditing

CE Marking IVD 98-79 EEC Implementation and Auditing, Essential Requirements Only

Quality Improvement Concepts -continuous improvements-problem solving and customer

FDA-GMP Good Laboratory Practice for nonclinical (21 CFR part58) Implementation and Auditing.

FMEA, Risk Analysis for Medical Devices

8 D Problem Solving Methodology, Corrective Action, and Good Business Practices

Business Continuity/Contingency Planning Implementation and Auditing/Auditor

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