Important Guidelines for MDSAP

The MDSAP (Medical Device Single Audit Program) is a three-year-long audit cycle. These cycles can be listed down as follows: The Initial Audit Cycle Partial Surveillance Audit Complete Re-audit The Initial Audit Cycle The initial audit cycle is the first year audit cycle and is also known as “Initial Certification…
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EU MDR Article 18 – Medical Device Implants

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…
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Technical File or Design Dossier Management – EU MDR

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?…
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EU PRRC – Person Responsible for Regulatory Compliance

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…
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EU MDR 2017 – 745 (Medical Device Regulations)

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…
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ISO 13485 – Insight into QMS Standard for Medical Devices

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…
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