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The world is changing. As Medical and Health Care knowledge gets more advanced by the day, our lifespans increase along with it. But as our understanding of these products becomes more advanced, this means that products theoretically thought to be beneficial for health have a certain level of risk to be either abused, unethically produced or inappropriately labelled. This can have serious repercussions if left unregulated. That is also where I step in. Using my extensive knowledge of scientific, legal and business issues acquired throughout different aspects of my work, my main role is to ensure the appropriate licensing, marketing and legal compliance of medical devices to make sure that they reach the end consumer safely. I see myself as a crucial link between the industry and the general public; as their bridge of trust to ensure that the medical products that they use are of a high quality standard and meet every guideline there is. Moving forward, I am always willing to meet people from both the medical and healthcare industry to share their experiences and stories. If you take an interest to what I do or wish to contact me for business and/or other opportunities, please feel free to connect with me Functional Areas of Focus: - Medical Devices (ISO 13485, ISO 14971, MDR, Quality Management Systems, Technical File Remediation, ISO 11607, ISO 14644, IQ OQ, PQ, FDA CFR 21, GMP, 510k, IEC 62304, IEC 82304, Complaint Handling, CAPA, Sterilisation, Software Validation, Computer System Validation CSV, eQMS, Article 10(9) QMS - Regulatory Affairs (RA) - Quality Assurance (QA/QC) - Biotechnology (SaMD, Digital Health, Artificial Intelligence/AI, Machine Learning) - PRRC (Person Responsible for Regulatory Compliance) - UKRP (UK Responsible Person) - eQMS (Qualio, Greenlight Guru, JIRA, Atlassian, G Suite) - Internal Auditor (IRCA) My Content: - How to build an ISO 13485 Quality Management System: Tinyurl.com/yagnzxm7 - ISO 13485 or ISO 9001 Quality Management Systems: Tinyurl.com/yavjg6kq - Medical Device CAPA (Corrective Action and Preventative Action): Tinyurl.com/ycqubsba - ISO13485 V FDA CFR 21 Part 820: Tinyurl.com/y94bkf5w - EU Medical Device Classifications: Tinyurl.com/yygdkdhw - How To Obtain A European CE Mark: Tinyurl.com/yxzplrr2 - What is UKCA and UKRP: Tinyurl.com/cus6teyy - What is UKNI: https://tinyurl.com/5nktadsy - What is an EC REP: https://tinyurl.com/59durub8 Follow me on YouTube @QRA Medical Follow my Podcast @The MedTech Podcast: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3
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