MEDICAL DEVICE REGULATORY SPECIALIST

I am a lawyer by profession and have been involved in the regulatory domain of the Medical Device Industry for the past 7 years. I initiated my work as a freelance consultant which led to the formation of my company in 2016 by the name of “Kounter Intuitive Technologies”. I am also working through the International Website KolabTree [https://www.kolabtree.com/find-an-expert/nida-a.25105] where I am one of their highly rated consultants. I have been engaged in the certification and quality management system of Medical Devices not only in Pakistan but all over Europe, US, Middle-East and Australia. I have joined Lifelab [https://lifelabtesting.com/author/nida-ali/] and Health Stuff Online Ltd.
[https://www.healthystuff.com/the-team/] in 2022 as the Regulatory Advisor and PRRC. I am providing Regulatory Consultancy to Healthy Stuff for their CE approval with regards to IVDR 2017/746. I am writhing blogs and articles on various medical aspects for Lifelabs. My work is focused towards compliance with FDA 510K and 21 CFR 820 Regulatory Framework, European Union Medical devices Regulation EU MDR 2017/745 and various ISO standards. I have Lead Auditor certifications in MDR 2017/745, ISO 13485:2016, ISO 14971:2019, ISO 9001 and a Human Resource Management diploma. I have complete expertise in compliance to ISO 10993-1:2018 and all its subcategories on various biocompatibility endpoints (e.g. in-vitro cytotoxicity, Genotoxicity, material mediated pyrogenicity etc.). I have worked with companies in USA (Shukla Medical, Ride Design, Mobility Research, QurVasc etc.) and in Europe (Arthro Dynamik, Stanpharma, RenovoDerm, AndraMed, AndraTec, Onlinebrands GmbH etc.) and Daiichi Medical Japan. I am a consultant for a UK based company Healthy Stuff Online Ltd. [https://www.healthystuff.com/the-team/].
I have made CERs for Cardiac Stents, Angioplasty balloon Catheters, Sutures, Ureteral Catheters, Dormia Baskets, Insulin Pen Needles, Ureteral dilators and access sheaths, and much more Class I, II, and III medical devices. All these reports have been accepted primarily by the European notified bodies and
successfully qualified audits. My clinical evaluation reports include input from medical physicians relevant to the medical device. A Biomedical Engineering PhD [Dr.Murtaza Najabat Ali https://www.linkedin.com/in/prof-dr-murtaza-najabat-ali-ceng-uk-fimeche-pe-55a4469/] and a Medical Specialist will review and sign the CER and their signed endorsed CV will be provided to you. The Clinical Evaluation will include the following:
1. CLINICAL EVALUATION PLAN
2. CLINICAL EVALUATION REPORT
3. LITERATURE REVIEW
4. VIGILANCE SEARCH PROTOCOL
5. SIGNED DECLARATION BY THE AUTHORS
6. SIGNED DECLARATION BY THE REVIEWERS
The well-published Biomedical Ph.D. Professor, has been extensively doing RnD and publishing a lot in medical devices, biomaterials, and drug delivery systems comprising of new drugs and new degradable polymers.
I have vast experience in developing Declaration of Conformity, Design and manufacture, PMS, HS Compliance Document IO 10993-1:2018, PMCF, GSPR, Risk Management Plans, Risk Management Reports, Verification and Validation, Technical File Summary Reports.
I have made Biological Evaluation Reports on ISO 10993-1:2018 and now on ISO 10993-1:2021 for Stainless Steel 410/420/304L/316, Cobalt-Chromium Alloy, Polycarbonate, Polyethylene, Polypropylene, Polyglycolic and PVC.