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Search for "13485"

Displaying results 1 to 9 out of 9

  “Modern qualification” and more – GMP experts spea... 81%

... Rühl AG. Challenges experienced in this actual project, concrete problems and solutions implemented according to ISO 13485:2016 and GMP are vividly described. All of this from two perspectives: that of the plant operator and contract ... February 2019 | 3:30 pm | Room 3 Six mistakes that make qualification an ordeal 6 February 2019 |1:30 pm | Room 3 ISO

  Qualification and validation of a fully automated ... 77%

... among others in the medical device industry, at its headquarters in Friedrichsdorf im Taunus. Rühl is DIN ISO 13485 certified and required the qualification and validation of a new, fully automated multi-product filing plant for ...

  Medical Devices 76%

... Pharmaceutical Product Manufacturer Definition and implementation of a supplier/outsourcing strategy, Q&R training ISO 13485:2016/US FDA QSReg/ISO 14971:2019 Medical Device Manufacturer EU MDR Class II/III Inspection readiness, ...

  EU MDR Consulting 70%

... requirements for the Quality Management System, now also as new requirements in lower product risk classes. ISO 13485:2016 as standard - this is not a "hard" requirement of the EU MDR, but a general expectation of Regulatory Authorities ... and work instructions, or the entire Quality Management System, are revised in accordance with the requirements of ISO

  MDSAP Compliance – Medical Device Single Audit Pro... 66%

... international quality management. It is lean and efficient. The MDSAP is based on the internationally recognized ISO 13485:2016 standard.  The following countries and their respective authorities accept the MDSAP as an option in their ...

  Medical Device Distributors and Importers – watch ... 65%

... the standard that will be used as the basis for a possible review/audit has not been defined yet. Presumably ISO 13485:2016 will play a role here, but to what extent remains unclear. Under what circumstances is repackaging or translation ...

  Compliance Consulting Medical Devices 63%

... – Passing Audits with Confidence and No Stress An audit by a notified body for (re)certification according to ISO 13485:2016 or an inspection by the responsible national authority or an international regulatory authority is coming up?  ...

  Compliance Consulting Medical Devices 63%

... – Passing Audits with Confidence and No Stress An audit by a notified body for (re)certification according to ISO 13485:2016 or an inspection by the responsible national authority or an international regulatory authority is coming up?  ...

  Regulatory Affairs - Safe Worldwide Product Approv... 62%

... the product, identifying risks and defining corrective measures. Requirements for this can be found in the EU MDR, ISO 13485:2016, the EU IVDR, as well as internationally, for example through US FDA Guidances or IMDRF Guidances. For each ...