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  • Document Changes

    Do font or color changes to a quality form require a document change notice?
  • Mock examples

    my question is we presently do not have business requiring 13485 however our registrar expects we have examples. We have many medical parts and more to come after we are certified.. I plan to set up a mock examples of how we would handle medical devices with the current parts we have. do you feel this is a good approach to demonstrate our readiness?
  • Clinical Evaluation Plan

    I have a task to complete to comply with MDR. My first priority is to write up a Clinical Eval Plan and then get it approved before starting the evaluation process. Question is what is a typical format would you recommend to use? This would be a Class 1 non invasive medical device that will be distributed in European countries.
  • FDA

    We are not a manufacturer of medical devices; we have designed and built a ventilator that we intend to submit to FDA for EUA approval. It is a novel design which has several advantages over current ventilators and is patent pending through PCT; two questions for you: 1.  Does the EU has also an emergency use authorization as FDA does for medical devices, specifically ventilators? 2. Are you familiarized with the process for EUA Authorization of the FDA?
  • Microbiology Lab for Implants (Plates and screws)

    Could you please help me to understand the requirements for the microbiology lab requirements for Orthopaedic Implants (Screw, Plates and Knees) to be complied with ISO 13485 and MDR 745 Requirements.
  • Creating validation report

    how to create validation report for new machine used at production floor?
  • Internal audit ISO 13485

    Hi does the internal audit checklist also cover the requirement for iso 9001? We got a non conformity for this.  
  • Career in medical devices space

    For someone interested in entering the medical devices space, can you advise on an approach to this side of the industry?
    What certifications are needed? What career ladder is there? What paths are possible? Can this be self-taught? Can you share your experience?

  • Packaging for non sterile product

    What is the requirements of managing a  flow of the process for non steriled category? we don't fall in the cleanroom criteria.we need just follow the controlled environment. Only problem is packaging outside the assembly line .so is it ok (or) will have to go for civil change. we primary packaging as polythin . we are mechanical ventilator manufacture with non sterile .  
  • Verification Inspection Reports

    We have been asked by the PRRC to manage Verification Inspection Reports for each batch release - said QA Manager could not release a batch if this VIR document is not  signed off by the PRRC. I have searched MDR and did not find this document above. My question is if this VIR exists, if yes if it is compulsory. If not, in what way PRRC is involved in batch release.
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