BSI Medical Devices’ Post

Listen back to our webinar 'Navigating your IVDR certification process for CE marking: How to work with your Notified Body for a sleek process'. This webinar looked at the key steps in BSI’s Certification/Review Process for CE marking under the IVDR and provided an overview of the key deliverables. The webinar also shares our lessons learnt to facilitate your interaction with Notified Bodies. Watch on demand: https://bit.ly/4cXWYWw #BSI #MedicalDevices #IVDR #CEmarking #Webinar

Informative overview of the lead times fron a big NB like BSI. One of the first questions i get from customers are "how long does certification take?", and its a hard one to answer. Even for us who are experienced. Note: the lead times are after signing of the agreement. not mean time including first contact and time leading upmtonsigning an agreement with the NB.

We are pleased to share BSI Notified Body capacity and lead times for MDR and IVDR applications and Conformity Assessments. This information is based on BSI’s interpretation of these terms, considering our operational processes and client feedback relating to information that would be the most useful in enhancing transparency and predictability of MDR/IVDR applications, and certification processes for manufacturers. BSI commits to updating the capacity and lead times on a regular basis, and the capacity and lead times presented below should be considered as indicative at the time of publication. Read the document here: https://bit.ly/3WNbI5j Visit our dedicated webpage: https://bit.ly/3QLgRqp #BSI #MedicalDevices #LeadTimes #MDR #IVDR

How long does it take for a QMS/Technical Documentation audit to happen once you've applied for it? 🤔 There has been an update on BSI Notified Body capacity and lead times for MDR and IVDR conformity assessments. The document details the types of conformity assessment applications the Notified Body is accepting and the average time it takes for them to carry out QMS and Technical Documentation audits from the time of application. #mdr #audit #NotifiedBody

All WA contacts! Government grants are opening up, for ISO certification. ISO 9001 (+others) have been some of the most strategic investments a company can make when it comes to building highly valuable, scalable and successful organisations. Other benefits can include a streamlined operation, raving customer base and market penetration. (But, please don't become a part of the large cohort of organisations that install this and have it be an expensive, annoying, laborious pain in the backside.....) .. Take advantage of this! https://lnkd.in/gtXSXqSK #westernaustralia #iso9001 #certification

Listen back to our Webinar on: Navigating your IVDR certification process for CE marking and get in touch if you have any questions, or would like to start working on your application #NotifiedBody #IVDR

Listen back to our webinar Navigating your IVDR certification process for CE marking: How to work with your Notified Body for a sleek process. This webinar looked at the key steps in BSI’s Certification/Review Process for CE marking under the IVDR and provided an overview of the key deliverables. The webinar also shares our lessons learnt to facilitate your interaction with Notified Bodies. Watch on demand: https://lnkd.in/eJp4ABAF #BSI #Medicaldevices #IVDR #CEmarking #Webinar

Listen back to our webinar Navigating your IVDR certification process for CE marking: How to work with your Notified Body for a sleek process. This webinar looked at the key steps in BSI’s Certification/Review Process for CE marking under the IVDR and provided an overview of the key deliverables. The webinar also shares our lessons learnt to facilitate your interaction with Notified Bodies. Watch on demand: https://lnkd.in/eVsgMrnY #BSI #Medicaldevices #IVDR #CEmarking #Webinar

Listen back to our webinar Navigating your IVDR certification process for CE marking: How to work with your Notified Body for a sleek process.   This webinar looked at the key steps in BSI’s Certification/Review Process for CE marking under the IVDR and provided an overview of the key deliverables. The webinar also shares our lessons learnt to facilitate your interaction with Notified Bodies.   Watch on demand: https://bit.ly/3viU9hW   #BSI #Medicaldevices #IVDR #CEmarking #Webinar

Another Formwork eQMS customer successfully passed their audit - congrats to Helena Ije and Better Medicine! :) Kind of surreal to see. ~4 years ago it was still just me, hacking away on an eQMS software prototype at night. Fast-forward a few years, and nowadays companies pass audits with it and save lots of time. (And don't worry, nowadays it's no longer only me coding at night, we now actually have software developers who work on it during the day, at least that's what they tell me) If you and your startup also want to pass medical device audits in record time, too, you should check it out. Prices start at 49€ / month: https://lnkd.in/eJaPZ7KS