mdsap (medical device single audit program)

  1. B

    MDSAP 8.2.6 CH6 task 17 ANVISA 16/2013 3.2.1 - Label History in Device history record

    Hi , I am new to the forum so apologies if I am posting incorrectly. During MDSAP audit a non conformance has been opened under MDSAP 8.2.6 CH6 Task17 , with respect to ANVISA 16/2013 3.2.1 as we do not keep copies of labels with the Device history record. Our current process is we keep a...
  2. XRAY_3121

    Design and Development Requirement - MDSAP Audit Finding

    Hi all, I work for a company that has no design and development files (they've been making same product with no changes for 50+ years - Lead aprons, dental xray film, etc.). We just had MDSAP audit under Annex II of MDD, so these files were expected. In my initial response I said we would...
  3. world217

    Informational MDSAP Substantial change / Change of notice forms

    Hello, First of all, I am sorry, as I was not sure if this is the correct thread where I should address this. We are currently preparing for MDSAP and right now I am working on having the Substantial change and change of notice forms for each country as per the requirements. However, they seem...
  4. XRAY_3121

    MDSAP Audit Findings - Document change orders

    I could really use some help from everyone on some audit findings. The first one is on document change orders. We were unable to produce all of the records requested (because the person responsible didn't complete them). They requested 3 DCO's and we only had 1. Yet this was marked as a...
  5. C

    CMDR Essential (Safety & Effectiveness) Requirements Checklist?

    We recently completed our MDSAP audit with Canada, USA, Australia and Europe in scope. As part of the Country Specific requirements, we have the checklists/template for Essential Requirements for Europe and Australia. Our auditor asked me for one for Canada.(CMDR 10-20 S&E reqts) There is no...
  6. M

    We still have not received our certificate due to a 'backlog' with our auditing body

    Hello everyone! Made an account here as we've run into an issue and I'm wondering if others are experiencing the same. Mid-2018 we recertified our medical device manufacturing facility to ISO 13485 under the MDSAP certification plan. We completed the audit with a few minor NC's and were...
  7. E

    MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP

    Hi there! We're a small Canadian company that manufactures medical devices for the Canadian and US markets and have a MDSAP audit scheduled for later this year. From what I've gathered online, the MDSAP program framework mainly consists of ISO 13485:2016 and GMP, in our case FDA 21 CFR Part...
  8. B

    MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device

    It's very normal case for in vitro diagnostic test kit to include lancing device. In our case, lancing device included in our test kit which is OEM product. I want to ask that OEM for lancing device needs to transition to MDSAP?
  9. Marcelo Antunes

    Medical Device News EU interesting developments – embracing MDSAP and UDI alignment

    Medical Devices: The EU will take steps to make use of single audit reports (an initiative of the International Medical Device Regulators Forum – IMDRF) in a manner that is compatible with EU legislative requirements. The EU and US will cooperate to ensure alignment of electronic database...
  10. T

    Change to Country of Origin on Medical Device Labeling

    Would a change in country of origin require notification to any of the MDSAP jurisdictions and/or the EU? The change has been approved by CBP, but didn't know if this labeling updating would require further notification since there is no safety-related update. Thanks!
  11. Marcelo Antunes

    Medical Device News MDSAP Stakeholder Day – December 5, 2018 presentations

    MDSAP Stakeholder Day Presentations – December 5, 2018 Continue reading...
  12. Ajit Basrur

    MDSAP Presentations - Dec 5, 2018 - Stakeholders

    The MDSAP Consortium has posted the Stakeholder Day presentations provided to manufacturers and trade organizations on December 5, 2018, at the Pan American Health Organization Headquarters in Washington, DC. See Medical Device Single Audit Program (MDSAP) - Stakeholders
  13. JoshuaFroud

    FDA Form MDSAP AU F0029.1.004 - Help with Completion

    Hello All I've finally received my dates from my AO regarding my MDSAP audit with stage 1 being at the end of January 2019 and stage 2 completed at the final facility in July 2019. I have located and am now completing to return the form "MDSAP AU F0029.1.004" available on the following FDA...
  14. supadrai

    Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones?

    Does anyone have the inside scoop - are all the NBs slammed this year and just trying to grind it out? Our customers are getting antsy about placing orders ... and the NB failed to respond completely for a month, then punted to another team without providing any good response. Thoughts? Ideas...
  15. Sidney Vianna

    Interesting Read Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate?

    The whole article is available @ MDSAP: When Is a Certificate Not a Certificate? | Quality Digest The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British...
  16. T

    MDSAP AO Cost

    Hi, my company is trying to get MDSAP AO certified We are at the very beginning stage of filling out the application and I have questions. How much would it cost be be a MDSAP AO? How stringent is AO assessment procedure? Thanks~~
  17. Q

    MDSAP Regions and how to include in procedures

    I am having an issue where during an internal audit I have discovered an Incomplete CAPA from last year. The initiator has determined via a MDSAP finding that references to external standards (EU, US, Japan, etc) were missing or being made inconsistently in some of our SOP's. The SOP's have...
  18. S

    Initial Importer and ISO 13485 (MDSAP) - Will the US company be included?

    If a parent company has a branch in the US who acts as the initial importer, is the parent or head office required to do an internal audit of the US distributor/initial importer? Note: the parent company has full control of the child initial importer. For the MDSAP audit of the head office...
  19. K

    MDSAP scope vs ISO 13485 Scope

    Does anyone know or had any experience of having the scope in the MDSAP cert differ from what is on the 13485? Is this possible? For my company, we have certain medical devices that we do not want to sell in Canada, but we do in the US.
  20. Marcelo Antunes

    Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan

    Health Canada - Notice: Medical Device Single Audit Program (MDSAP) Transition Plan - Frequently Asked Questions (FAQ) Notice: Medical Device Single Audit Program (MDSAP) Transition Plan - Frequently Asked Questions (FAQ) -
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