Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, contact our expert team who will guide you through the process. Call us:+852 3149 3300 Email:hk@bsigroup.com Contact us form...
Of course, you can also decide to keep it as a digital document and use it as so. In case you decide to print it, we recommend to test a couple of pages before printing the full document to ensure you have the right settings in you printer. Let's protect the environment!
In carrying out risk management manufacturers shall: (a) establish and document a risk management plan for each device; (b) identify and analyse the known and foreseeable hazards associated with each device; (c) estimate and evaluate the risks associated with, and occurring during, the intended ...
Available add-ons Advanced Security Enterprise-grade security features GitHub Copilot Enterprise-grade AI features Premium Support Enterprise-grade 24/7 support Pricing Search or jump to... Search code, repositories, users, issues, pull requests... Provide feedback We read every piece of ...
Publication of an update to the 2020 Manufacturer’s Incident Report (MIR) form,new version 7.2.1together with aQuestionsand Answersdocument on implementation. Publication a new MDCG guidance:MDCG 2020-10/1on Safety reporting in clinical investigations together withMDCG 2020-10/2the Clinical Inves...
Once each gap is closed, you will establish full compliance. This tool is also tremendously important to make use of the “soft transition” with your MDD certificate. This document as well provides for the MDD compliance. It fully supports the MDD certificate for the time being. Meaning you...
TO BE PROVIDED FOR ASSESSMENT TYPE OF ASSESSMENT: INITIAL | MODIFICATION | EXTENSION | RENEWAL REGULATION (EU) 2017/745 JUNE 2020 EDITION TECHNICAL MEMO FOR GMED CUSTOMERS ONLY AND APPLICABLE ONCE GMED IS DESIGNATED UNDER REGULATION (EU) 2017/745 GMED property document - 720 RDM 0801-2a Rev. ...
Only wild type form of Pfmdr1-86 was detected in both groups. 3.2. Prevalence of Pfcrt-76 haplotypes varies between study sites and P. vivax co-endemicity Overall, the wild type Pfcrt-K76 haplotype was detected in 23.7% (40/169) and the mutant Pfcrt-76T in 76.3% (129/169) of ...
The MDCG document provides detailed information on what should be considered invasive and/or burdensome. There is guidance on how to determine if the planned use of the device in a clinical investigation is covered by the intended purpose. The sponsor of the PMCF s...
Another significant trend relates to the rapid growth in devices utilizing Artificial Intelligence and Machine Learning. The FDA signaled that a guidance document describing use of algorithm change protocols is on the list of guidance priorities for 2023. This guidance would describe the types of chang...