Waqas Imam, Author at TSQ Middle East & Asia

EU MDR Article 18 – Medical Device Implants

By Waqas Imam0 CommentsGeneral

Article 18 of MDR addresses the need for an implant card for implantable medical devices. For an Asian implantable devices manufacturer, fulfilling the requirements of EU MDR Article 18 without an EU Authorized Representative might not be possible. What are the Requirements of EU MDR Article 18? EU MDR Article…

The Need of EU Authorized Representatives for Asian Medical Device Manufacturers

By Waqas Imam0 CommentsGeneral

Why is there a Need for EU Authorized Representative? Appointing an Authorized Representative is necessary for non-EU-based medical device manufacturers. If a manufacturer does not nominate the Authorized Representative to repent him in Europe, the Notified Body will not issue him the CE certification. Moreover, every manufacture is also required…

Managing DHF – Design History File Control for Medical Devices

By Waqas Imam0 CommentsGeneral

The United States Code of Federal Regulations Title 21 defines the DHF and its purpose for medical device manufacturers. According to Section 820.3(e) of the Federal Regulations: “Design History File (DHF) means a compilation of records which describes the design history of a finished device.” Similarly, Section 820.30(j) of the…

Managing EU Authorized Representative Requirement – EU MDR

By Waqas Imam0 CommentsGeneral

Medical device manufacturing organizations are scattered all around the globe. Some of them are localized into countries, while others have managed to spread their operations globally, and many are still struggling to do so. Those medical device manufacturing organizations that want to expand their operations in Europe have to comply…

Technical File or Design Dossier Management – EU MDR

By Waqas Imam0 CommentsGeneral

A CE Technical File or Design Dossier is a complete description for a medical device intending to show compliance with EU MDR’s requirements. For a medical device manufacturer, preparing a technical file or design dossier is an essential step in Europe’s CE marketing process. What does the Technical File/Dossier Contain?…

EU PRRC – Person Responsible for Regulatory Compliance

By Waqas Imam0 CommentsGeneral

The new regulations, i.e., EU MDR (2017/745) and EU IVDR (2017/746) have made regulatory requirements for medical device manufacturers more stringent. It is now mandatory for medical device manufacturing companies to ensure that they have a qualified and competent Regulatory Expert who can help them become compliant with the new…

EU MDR 2017 – 745 (Medical Device Regulations)

By Waqas Imam0 CommentsGeneral

What are Medical Devices? Medical devices are the medical equipment and devices used for in vitro tests. These devices are either used in hospitals by healthcare professionals or directly by a patient. The EU market contains around 500,000 different types of medical devices. All of these devices are used for…

ISO 14971 – Quick Review of Medical Devices’ Risk Management Standard

By Waqas Imam0 CommentsGeneral

Industrial standards that regulate the medical device industry are vital in ensuring the safety of users of the medical device. One of such standards is ISO 14971. ISO 14971 particularly deals with risk management associated with medical devices. An organization that understands the basics of the risk management process is…

ISO 13485 – Insight into QMS Standard for Medical Devices

By Waqas Imam0 CommentsGeneral

The latest version of ISO 13485 primarily emphasizes regulatory compliance. For an organization seeking to show compliance to ISO 13485, it must meet all the standard’s applicable regulatory requirements. Therefore, it is important for both medical device manufacturing companies and medical start-ups to understand this standard’s regulatory requirements. The Quality…

The MDR’s Usability Requirements

By Waqas Imam0 CommentsGeneral

Rules, regulations, and legislations are very necessary to keep the processes running smoothly. The EU has proposed its new Medical Device Regulations (MDR) replacing the old Medical Device Directive (MDD) although the implementation of MDR has been postponed till 26th May, 2022. The MDR proposes several usability requirements for the…

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Author: Waqas Imam

EU MDR Article 18 – Medical Device Implants

The Need of EU Authorized Representatives for Asian Medical Device Manufacturers

Managing DHF – Design History File Control for Medical Devices

Managing EU Authorized Representative Requirement – EU MDR

Technical File or Design Dossier Management – EU MDR

EU PRRC – Person Responsible for Regulatory Compliance

EU MDR 2017 – 745 (Medical Device Regulations)

ISO 14971 – Quick Review of Medical Devices’ Risk Management Standard

ISO 13485 – Insight into QMS Standard for Medical Devices

The MDR’s Usability Requirements

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