Implement & Measure ISO 13485:2016: Medical Devices Standard Using Manreqa Risk Software. Manage Quality Throughout the Life Cycle of a Medical Device using ISO ERP.

ISO 13485:2016 Risk Soft. Model Med Dvc 7 Gold.
₹ 2,500 / Month / User. Paid Once- ₹ 30,000=00
25% AMC on Yearly Basis for Risk Software.
ISO 13485:2016: Medical Devices Standard Using Manreqa Risk Software
  •   Risk Assessment Software
  •   Issue Register
  •   Issue Review and Action Plans
  •   Needs & Expectations
  •   Risk Procedure, Manual & WI
  •   M2 Mitigation Task to High Risk
  •   Proc/WI Numbering and Audit Frequency
  •   Audit Schedule
  •   Risk Procedure Audits
  •   Audit Deviation List
  •   DAR
  •   CAR
  •   Improvement Opportunities
  •   ISO 13485:2016 Indexing
  • ❌   Draft Business Areas.
  • ❌   Draft Needs & Expectations.
  • ❌   Draft Risk Procedures
  • ❌   Draft Document Info Manual (Quality Manual)



  1. Training Videos. Extra of ₹ 4,500=00
  2. If Required, 4 Multi Users / Client Pack. Cost is ₹ 90 /per Users, ₹ 360 Per Month Paid Yearly. ₹ 4320=00 / year.
Download ISO 13485:2016 Risk Soft. Model Med Dvc 7 Gold Implementation Tool Kit
Download Scope Video for ISO 13485:2016 Risk Soft. Model Med Dvc 7 Gold.
ISO 13485:2016 Risk Soft. Model Med Dvc. 8 Premium.
₹ 3,500 / Month / User. Paid Once ₹ 42,000.00
25% AMC on Yearly Basis for Risk Software.
ISO 13485:2016: Medical Devices Premium Manreqa Risk Software.
  •   Risk Assessment Software (Single User)
  •   Issue Register
  •   Issue Review and Action Plans
  •   Needs & Expectations
  •   Risk Procedure, Manual & WI
  •   M2 Mitigation Task to High Risk
  •   Proc/WI Numbering and Audit Frequency
  •   Audit Schedule
  •   Risk Procedure Audits
  •   Audit Deviation List
  •   DAR
  •   CAR
  •   Improvement Opportunities
  •   ISO 13485:2016 Indexing : Free.
  •   Draft ISO 13485:2016 Business Areas : Free.
  •   Draft ISO 13485:2016 Needs & Expectations: Rs/- 3,500=00
  •   Draft ISO 13485:2016 Risk Procedures : Rs/- 5,500=00
  •   Draft ISO 13485:2016 Document Info Manual : Rs/- 4,500=00
  •   Training Videos : ₹ 4,500=00
  1. If Required, 4 Multi Users / Client Pack. Cost is ₹ 90 / per Users, ₹ 360 Per Month Paid Yearly. ₹ 4320=00 / year.
  2. Where Necessary, the Physical Hand Holding Visit for Training & Consultation will Cost Extra.
Download ISO 13485:2016 Risk Soft. Model Med Dvc. 8 Premium, Implementation Tool Kit
Download Video ISO 13485:2016 Risk Soft. Model Med Dvc. 8 Premium.

Why We ?

  1. We Assist Clients to "Establish Quality" and "Demonstrate Quality".
  2. We Assist Clients to "Embrace Systems" and "Practice Systems".
  3. For us ISO 9001 2015/ISO 13485:2016 is a “Platform” for Business Growth, not a Tool to Obtain an ISO 13485:2016 Certificate.

Benifits of Risk Based Software.

  1. With our tools, you yourself, can drive the ISO 9001 2015 program in your company.
  2. Several Training Videos enable users to learn themselves, at their own pace & implement ISO 13485:2016 standard.
  3. A high-quality tool, that helps to capture requirements of ISO 13485:2016 standard.
  4. Rank your Systems. i.e. Degree of system implementation by a score card similar to our education marks sheet.
  5. High chances of getting “Approved Vendor” tag from OEM Customer. Retain the Approved Status by having high rankings/ratings from customer audits. Get appreciation and build trust & confidence with customers for getting orders, by showcasing your high-quality implemented ISO systems.
  6. Manreqa a Risk-Based Software, takes control of internal systems and digitizes the ISO 13485:2016 Adequacy documents.
  7. A tool exclusive for an MR/Quality Coordinator who can easily understand, can easily operate and therefore it will be up & live within a shorter period.

FAQ : ISO 13485:2016 : Frequently Asked Questions?

Preparation for ISO 13485:2016 Certification Audits

  1. What are the Step to get Certified to ISO 13485:2016?
  2. How do I get ISO 13485:2016 certified?
  3. How ISO 13485:2016 is implemented?
  4. What are principles of ISO 13485:2016?
  5. How to Identify Risk Levels (i.e. High Risk, Low Risk, Medium Risk).
  6. What are Risk & Opportunities in ISO 13485:2016? or What is Risk & Opportunities in ISO 13485:2016?
  7. How do you identify Risk & Opportunities?
  8. What are 3 types of Risks?
  9. How is a Risk Assessed?
  10. How to Mitigate a Risk in ISO 13485:2016?
  11. What is action to address Risk & Opportunities in ISO 13485:2016?
  12. What is "Needs & Expectations" of ISO 13485:2016? ?
  13. How to Understand the Needs & Expectations of Interested Parties?
  14. What are Interested Internal & External Parties in ISO 13485:2016?
  15. How to Identify Interested Internal & External Parties in ISO 13485:2016?
  16. What is ISO 13485:2016 certification audit?
  17. What do ISO 13485:2016 auditors look for?
  18. How to prepare for an ISO internal ISO 13485:2016 audit?
  19. Questions asked during the ISO 9001 certification audit?
  20. ISO 9001 Audit check list by a certification auditor?
  21. What is the duration of iso ISO 13485:2016 certificate?
  22. What is the high level structure of ISO 13485:2016?
  23. From where can I download the ISO 9001:2015 documentation toolkit for free?
  24. What is the best way to prepare employees for an audit?
  25. What are common misconceptions about ISO 9001:2015?
  26. What is the duration of ISO 13485:2016 certificate?
  27. What do I do to prepare for an audit?
  28. Who can help employees prepare for implementing ISO 13485:2016?
  29. How many clauses are there in the ISO 13485:2016 standard?
  30. What is difference between ISO 9001 2015 & ISO 13485:2016?
  31. What is difference between Previous version of ISO 13485 2003 & Latest the ISO 13485:2016?

    32. Preparation for ISO 13485:2016 Surveillance Audits

  32. What is ISO 13485:2016 surveillance audit?
  33. How to prepare for an ISO 13485:2016 surveillance audit?
  34. What do ISO 13485:2016 auditors looks in Surveillance?
  35. What are the steps to maintain ISO 13485:2016 certification Status?
  36. What you should prepare for ISO 13485:2016 surveillance audit?
  37. How do you know if your ISO ISO 13485:2016 certificate is genuine?