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forms and templates (general)

  1. U

    Electronic templates for making paper control charts

    Does anyone have electronic templates for making paper control charts? I am looking to print blank control charts for use on the manufacturing floor. It seems that everyone has migrated to electronic SPC. What good is a control chart in your computer unless you have a computer at every...
  2. optomist1

    Share a DFMEA template please

    Can anyone share a DFMEA template...a cursory search revealed DFMEA matrices, but no DFMEA template....additionally for those Cove software experts, please share any current experience re: validation and vetting of deliverable software, tools, processes etc...Thank You
  3. alonFAI

    Please share a medical device company NCMR procedure

    Hi Guys, can anyone share an NCMR (nonconforming material report) procedure of a medical device company? I want to see how it is managed. 1. lets say I use contract manufacturer to manufacture my medical device. 2. during incoming inspection inc case there is a problem with the device, then I...
  4. K

    Does anyone have a copy of a GM 5 Phase Problem solving form

    Looking for a Copy of a General Motors 5 Phase Problem solving form
  5. P

    Looking for Risk Assessment Template - Not necessarily Asset based

    Hi, Most of the Risk assessment templates that I have seen are all Asset based. You start with asset register, and look for risks and mitigation plans. I guess that was a standard approach in ISO 27001:2005. There are a couple of templates on the internet, however they are again asset based...
  6. A

    Australia TGA Medical Device Sponsor Agreement - Example or Template

    Does anyone have an example of or template for a Medical Device Sponsor Agreement for Australia?
  7. F

    Guidance in English for PMS requirements for Taiwan

    Hi, I am unable to find the Guidance in English for PMS requirements for Taiwan. Does anyone have this translated or a similar presentation or template procedures for adverse event reporting and field corrections in Taiwan, I would be greatly appreciative. Thanks!
  8. D

    Templates for Environmental, Safety and quality Management System wanted

    Dear all, Am a small scale SME in Africa am looking for templates for environmental, safety and quality Management systems .Those who may have kindly share.
  9. J

    Lean MFG (manufacturing) process and Work order templates

    Hi, my name is Johnnie, supervisor at a small but rapidly growing mfg/engineering company. I recently became supervisor in our NPI department to control the flow of the floor. My new manager wanted to run in a lean process or six sigma. New to my company and not much experienced personnel here...
  10. S

    Medical device CER (clinical evaluation report) according to MDR

    hello, I'm looking for clinical evaluation report (CER) template according to the new medical device regulation (MDR) not Meddev 2.7 rev 4. I'm also looking for templates for clinical evaluation plan , PMCF (post marketing clinical follow up) could anyone help me? thank you sebastien
  11. R

    SaMD - Software as a Medical Device - Software change control form

    Hello everyone, For a company that makes SaMD, (software as a medical device), does anyone have a design change control form template? I know in the world of hardware devices, there are engineering change controls and the associated forms where you assess the impact. Does the world of software...
  12. K

    Work Order Form (Controlled Document)?

    Question? I work at a company that uses a Work Order Form for Material Verification, Label Verification, and the different operations(Lamination, Slitting, etc..) it would take to create a part for other automotive companies. Each work order has a unique number to trace it by, but I am...
  13. M

    Does anyone has a good verification and validation plan template?

    Hi, Does anyone has a good verification and validation plan template? Thanks
  14. Ashok sunder

    ISO 45001:2018 Documentation template

    Dear All, could you Pls provide the ISO 45001:2018 Documentation template?
  15. J

    Medical Device Vigilance decision tree FORM - Please share yours

    Hi Everyone, Can anyone please share their vigilance reporting tree form under MDD. I created a flow chart but that is not considered a documentation summarizing for the person in charge of vigilance reporting. We have a SOP and our current plan is to create a form describing the flow chart...
  16. E

    Template of a Management Review Agenda or Report in compliance with ISO 13485:2016

    Management Review Agenda or Report to ISO 13485 : 2016 ( not to ISO 9001:2015)?
  17. M

    SOPs, Plans and Report templates for Clinical Evaluation of EU MDR

    Dear all I am looking for SOPs, plans and report template for Clinical Evaluation related matters of MDR (i.e. Clinical Investigation, PMS, PMCF, CER, PSUR etc.) Does anyone have these I can use? If not, I see that A.P.Lyon (from the US it seems) are selling SOPs for the entire Clinical...
  18. S

    Source of QMS templates including templates for design verification/design validation

    Hi everyone, Does anyone know a good source of QMS templates including templates for design verification/design validation documents as well as device history record documents? While I have a good idea of what to construct for these templates, I would like to see what others have done to see...
  19. W

    ERP Audit Trail audit by FDA? Regular audit trail report template?

    Hi folks, I wonder if someone can give me hints for how an "audit trail report" of an ERP (Electronic Resource Planning) system should look like to fulfill the requirements of FDA Quality System audits of medical device manufacturers? We are a small start-up, have a QMS (13485:2016...
  20. J

    IVDR and MDR ANNEX I Requirements Template

    The Annex I of new regulations appear to be the new version of Annex I Essential Requirements in the directives. I wonder if there is any template out there created like the Essential Requirement Checklist?
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