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U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, will accept the MDSAP audit reports as a substitute for FDA routine inspections (biennial by policy). Additional benefits include: · 1. MDSAP routine audits are announced, scheduled by the Auditing Organization with the manufacturer, with a pre-established duration; 2. The FDA will review MDSAP audit reports with a level of scrutiny commensurate to the significance of audit findings, taking into account the review and follow-up performed by the Auditing Organization; · 3. Firms have one month to provide their full response to critical nonconformities (grade 4 and 5) to the Auditing Organization (as opposed to 15 working days following and FDA inspection); 4. Certification documents issued by the Auditing Organization state compliance with applicable US regulations, which may provide a marketing advantage. Note: Inspections conducted “For Cause” or “Compliance Follow-up” by FDA will not be affected by this program. Moreover, this MDSAP program would not apply to any necessary pre-approval or post approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device. Brazil The Brazilian National Health Surveillance Agency - ANVISA utilizes the outcomes of the MDSAP program, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support regulatory technical evaluation on these issues. As defined in RDC 15/2014 and RE 2.347/2015, ANVISA may use MDSAP audits in lieu of a premarket inspection by ANVISA to grant ANVISA’s GMP Certificate to manufacturers intending to put medical devices of class III or IV on the Brazilian market. Undergoing an MDSAP audit may accelerate ANVISA´s GMP certification process, which is a pre-requisite to the marketing authorization. ANVISA can also use MDSAP audits to renew ANVISA’s GMP Certificate biannually, as an alternative to an ANVISA comprehensive inspection. Some participating regulatory authorities will use MDSAP audit outcomes as an alternative to their own inspections to process applications for medical device marketing authorization.

Answering to your question 1. We provide services for all class of medical devices depending on the country of interest and the certification you wish to pursue. 2. Yes, we exclusively work for medical and IVD devices.

Hello Premila, Thanks for your validation & appreciation!

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ec.europa.eu/tools/eudamed/#/screen/search-eo Please ensure to select the role as Authorized Representative and then press search.

Glad to hear that

Thanks for your comment, we shall review & rectify it.

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Hello, Thanks for your comment. We are into Medical Devices only.

UKCA is only applicable for Medical Devices

Only the Medical devices are required to have UKCA

Hello, MRM = Management Review Meeting CAPA = Corrective Action & Preventive Action.

@@MavenProfconServicesLLP Thanks so much

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CE MARK OR UKCA MARK ONLY GET USE ON MADICATED DEVICES ? OR WE GOT UKCA OR CE MARK GET USED ON TEXTILES PRODUCT ? PLZ EXPLAIN BRIEFLY

It is an organization nominated to exercise authority, power of approval and acceptance or rejection of CE certification to Medical device manufacturer on behalf of concerned government of the member state. They are the ultimate authority and their decision decides whether a manufacturer is eligible to be CE certified. You can refer below link for the list of Competent Authorities: ec.europa.eu/tools/eudamed/#/screen/competent-authorities

@@MavenProfconServicesLLP then what is the role of Notified body ?? I thought they provide CE certificate ??

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Glad to know that!

Glad it was helpful!

Thanks ✌️

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There are several changes that have come into place after the MDD to MDR transition. Please watch this video for more information. th-cam.com/video/XgNeEQxGNuE/w-d-xo.html

@@MavenProfconServicesLLP Yes, video is correct. On my first comment concerning 93/42/EEc I was referring to clinical evaluation requirements (I was unclear). I'm a freelancer on class IIb implantable devices CE mark documentation preparation (including clinical research, FMEA, Risk analysis/Management, etc.) Should you be interested in a new partner (located in Europe) feel free to let me know.

@@jimk8592 Sure, it's our pleasure. Kindly connect with us at enquiry@mavenprofserv.com

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Thanks for your comment. Yes, SSCP is required for Class III, irrelevant of whether it is implantable or not.

Very true, it is our mistake we have mentioned it for Class I (r, s, m), whereas it is excluded for Class I (r, s, m)

We appreciate your comment. The table mentions it correctly, but the description has errors.

Thank you Ramesh Kakani