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  • ISO 13485 compatibility with EN 14126

    Is ISO 13485 compatible with EN14126?

  • Requirement of mentioning details of outsourced process in Clause 4.1.5 of ISO 13485

    In the clause 4.1.5 of ISO 13485 (which talks about the outsourcing of any process by an organization), is it required to mention details of the outsourced process while drafting the document? And, can you elaborate on the controlling and documentation of such a process? If you can provide an example of how an organization documents clause 4 for the ISO 13485.

  • Objectives for Textile Unit manufacturing isolation gowns

    What Objectives can we have for a Textile Unit manufacturing ISOLATION GOWNS?

  • Effect of medical device class on ISO 13485 documentation

    1. I would like to know how the class of a medical device affect in the documentation required to implement a quality management system according to ISO13485:2016.  

    2. I mean if we manufacturing the medical device of class IIa (specifically a gamma probe) what type of certifications should have it. (IEC60601 for electromedical equipment, electromagnetic compatibility, among other).

    3. It's possible to know all documentation that is necessary for design and manufacturing gamma probes? thanks 

  • Evolving QMS system of home blood test kit

    We need to evolve a QMS system of our home blood test kit, which included a specimen collection device. We need to produce a Declaration of Conformity and be CE ASAP. What is the quickest way to go about this?

  • Regulatory requirements applicable for Ventilators

    What are the regulatory requirements applicable for Ventilators?

  • Risk based approach in ISO 13485

    1. Has there been a noticeable improvement with the implementation of 13485:2016 with the risk-based thinking approach?

    2. What must companies do in advance to prepare for the stringent requirements in Eu MDR handling of complaints? 

  • ISO 13485 for outsourced supplier – is it necessary?

    Hello, I am a Auditor/Consultant and I have a client that is a outsourced supplier (Specialized Outsourcing Services, integrating the assembly of electronic boards, wiring harness and electronic equipment) who works with several MD companies, but without any finished product and he has no Design and development once all production is done under client specifications. He asked me to determine if ISO 13485 was a good option for his company once his scope is only on production involved in one or more stages of the life-cycle of a medical device and he is already ISO 9001 certified. ISO 13485 is mainly for finished product suppliers so it´s no mandatory for this client, but there can be some interesting point evaluating if it is a good option. I must present an overview /report to support management decision about ISO 13485 certification or not. If they decide to go on certification, do you have a solution for this? 

  • Is written procedure required for internal Audit if audit is outsourced to outside consultant?

    Hi, Is it required by ISO 13485 to have a written procedure for "Internal Audit" if the company always hires a qualified consultant from outside the company to perform the internal audit? No one internally. Always outsourced for internal audit (once a year).

  • Which aspects of MDR compliance should be main priority?

    With a wide range of products and limited resources which aspects of MDR compliance should be the main priority?
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