Maven Profcon Services LLP is a service provider for Consultation, Audits, Trainings, GAP audits, Conformity Assessments, Various Evaluation, Documents Review & Testing. Supported with the team of Management Graduates, Engineering Graduates, Technical experts, Subject experts, Trainers and lead auditors.
Our services are in diversified dimensions to cater manufacturing and service organizations.Organization has Association with some of the top professionals for sharing of technical expertise in different area. These individuals have revolutionized the concept of providing Quality Services by Medium & Large organizations.
I am still confused are you guys saying that if I have MDSAP certification then i dont need USFDA certification to sell in US market or Anvisa Certification to sell in Brazil market??
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.
Very Informative Video Adaresh ! My appreciation to Maven for providing regulatory audit services with additional benefits. This is the most important things we need to maintain in our Pharmaceutical field specially Medical Devices Industries. You are working on it. Keep it up..
Flawless presentation. Adding two queries here. 1. For what types/classes of medical devices do you provide this service for? 2. Is this service only provided for medical device quality management?
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.
Sir ukca mark only applay medical product? or applay all product that comes in uk out side the uk ? I am selling normal to shirt so is applay ukca code on it or not ?
Sir I am manufacturing shirt from china and sand to uk so is it required ukca certificate and mark aswell on it ? Ukca certificate we get it or chines manufactuer get arrange ukca certificate ?
Sir ukca mark and certificate requieed all product that we import in uk from china or any specific medicated productes that this ukca certificate applay on it?
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
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Hello Bhavan, we are glad that you are interested in working with us. You can follow us on social media, watch our videos and research more on those topics, to begin with. If you want to send us your resume you can send it to support@mavenprofserv.com Also, check out www.mavenprofserv.com/ our website, you can also read upcoming blogs and articles that we post on the website. Stay connected!
There are several changes that have come into place after the MDD to MDR transition. Please watch this video for more information. ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-XgNeEQxGNuE.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.
In addition; procedure pack assembler and manufacturer of class I (r, s, m) will not be asked for technical documentation auditing, only microbiology audit for procedure packs, and QMS/Microbiology auditing for Class I (r, s, m)
This training contains mistakes, PSUR for class IIb is required annually not every 2 years, no difference between class IIb non-implantable or implantable, both the same in PSUR requirements, this wrong info was introduced at definition slide
