Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction was to be reoccur.
As EU MDR has already entered into force and will be applicable in May 2020, the device companies are getting geared up to be MDR compliant. EU MDR enforces stringent requirements related to clinical evidence and post marketing obligations on device companies in proportion with risk class and the type of device.
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Pioneering Quality and Compliance in Ophthalmology At Ophtechnics Unlimited, we are proud to announce that we are the first company in India to achieve CE Certification under the EU MDR 2017/745 for our Schirmer Tear Test Strips. This milestone is not just a testament to our commitment to quality but also to our dedication to advancing ophthalmic diagnostics through rigorous compliance and innovation.
The Medical Device Vigilance Market is primarily driven by two key drivers. Firstly, technological advancements have paved the way for improved methods of collecting and analyzing data related to medical device safety.
The Challenges of Multi-Drug Resistant (MDR) Tuberculosis ... Obtain sputum for laboratory analysis. Wait for results. Treatment. 1. Isolate the case ...
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Demystify Software As Medical Device compliance with our guide to CE marking for medical software - ensuring your innovation meets regulatory standards effortlessly. The CE marking for SaMD stands as a testament to compliance with European regulations, underscoring a commitment to meeting stringent standards in the development and deployment of software within the medical domain.
Ensure compliance effortlessly! Your guide to CE marking for Annex XVI products regulations for seamless market access. In the world of product manufacturing and distribution, compliance with safety standards is of utmost importance. In particular, Annex-XVI products require special attention when it comes to meeting regulatory requirements. This is where CE marking comes into play.
Conformity Assessment Procedure for Medical Device under the Responsible Model (EU MDR 2017/745 & EU IVDR 2017/746). A medical device manufacturer has to follow Conformity Assessment Procedure before placing the device on the EU Market. These conformity assessment procedures are documented in Article 52 of the EU MDR 2017/745 for Medical Devices & Article 48 of EU IVDR 2017/746 for Invitro Diagnostic Medical Device.
Conformity Assessment Procedure for Medical Device under the Responsible Model (EU MDR 2017/745 & EU IVDR 2017/746). A medical device manufacturer has to follow Conformity Assessment Procedure before placing the device on the EU Market. These conformity assessment procedures are documented in Article 52 of the EU MDR 2017/745 for Medical Devices & Article 48 of EU IVDR 2017/746 for Invitro Diagnostic Medical Device.
We help you to prepare Medical Device Technical File (MDR) as per the regulatory requirement of EU MDR 745/2017 and submit to notified body for review and approval of CE certification. In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees medical devices registration. Operating under the Ministry of Health and Family Welfare, DGDA regulates the import, production, distribution, and sale of medical devices, emphasizing quality and safety standards.
We help you to prepare Medical Device Technical File (MDR) as per the regulatory requirement of EU MDR 745/2017 and submit to notified body for review and approval of CE certification. In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees medical devices registration. Operating under the Ministry of Health and Family Welfare, DGDA regulates the import, production, distribution, and sale of medical devices, emphasizing quality and safety standards.
We help you to prepare Medical Device Technical File (MDR) as per the regulatory requirement of EU MDR 745/2017 and submit to notified body for review and approval of CE certification. In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees medical devices registration. Operating under the Ministry of Health and Family Welfare, DGDA regulates the import, production, distribution, and sale of medical devices, emphasizing quality and safety standards.
We help you to prepare Medical Device Technical File (MDR) as per the regulatory requirement of EU MDR 745/2017 and submit to notified body for review and approval of CE certification. In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees medical devices registration. Operating under the Ministry of Health and Family Welfare, DGDA regulates the import, production, distribution, and sale of medical devices, emphasizing quality and safety standards.
We help you to prepare Medical Device Technical File (MDR) as per the regulatory requirement of EU MDR 745/2017 and submit to notified body for review and approval of CE certification. In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees medical devices registration. Operating under the Ministry of Health and Family Welfare, DGDA regulates the import, production, distribution, and sale of medical devices, emphasizing quality and safety standards.
We help you to prepare Medical Device Technical File (MDR) as per the regulatory requirement of EU MDR 745/2017 and submit to notified body for review and approval of CE certification. In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees medical devices registration. Operating under the Ministry of Health and Family Welfare, DGDA regulates the import, production, distribution, and sale of medical devices, emphasizing quality and safety standards.
We help you to prepare Medical Device Technical File (MDR) as per the regulatory requirement of EU MDR 745/2017 and submit to notified body for review and approval of CE certification. In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees medical devices registration. Operating under the Ministry of Health and Family Welfare, DGDA regulates the import, production, distribution, and sale of medical devices, emphasizing quality and safety standards.
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Unleash the Power of Medical Device Excellence with Insightful CE Marking. Elevate Performance, Ensure Compliance – Your Gateway to Success! we understand that the CE certification process for medical devices can be a complex journey that requires informed guidance through every step and meticulous attention to detail and hence we offer a versatile team of experts to coach you through every step with personalized support.
Ensure your packaging meets standards with expert packaging validation. Trust us for reliable compliance every time. Packaging validation is a critical aspect of ensuring the safety and effectiveness of medical devices. It involves a comprehensive evaluation of packaging equipment, materials, and designs, as well as processing variables that impact the ability of a packaged device to meet its acceptance requirements. This process is essential for preserving the sterility of medical devices, protecting their functionality, and ensuring their biological safety.
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Ensure your packaging meets standards with expert packaging validation. Trust us for reliable compliance every time. Packaging validation is a critical aspect of ensuring the safety and effectiveness of medical devices. It involves a comprehensive evaluation of packaging equipment, materials, and designs, as well as processing variables that impact the ability of a packaged device to meet its acceptance requirements. This process is essential for preserving the sterility of medical devices, protecting their functionality, and ensuring their biological safety.
Ensure your packaging meets standards with expert packaging validation. Trust us for reliable compliance every time. Packaging validation is a critical aspect of ensuring the safety and effectiveness of medical devices. It involves a comprehensive evaluation of packaging equipment, materials, and designs, as well as processing variables that impact the ability of a packaged device to meet its acceptance requirements. This process is essential for preserving the sterility of medical devices, protecting their functionality, and ensuring their biological safety.
Ensure your packaging meets standards with expert packaging validation. Trust us for reliable compliance every time. Packaging validation is a critical aspect of ensuring the safety and effectiveness of medical devices. It involves a comprehensive evaluation of packaging equipment, materials, and designs, as well as processing variables that impact the ability of a packaged device to meet its acceptance requirements. This process is essential for preserving the sterility of medical devices, protecting their functionality, and ensuring their biological safety.
Ensure your packaging meets standards with expert packaging validation. Trust us for reliable compliance every time. Packaging validation is a critical aspect of ensuring the safety and effectiveness of medical devices. It involves a comprehensive evaluation of packaging equipment, materials, and designs, as well as processing variables that impact the ability of a packaged device to meet its acceptance requirements. This process is essential for preserving the sterility of medical devices, protecting their functionality, and ensuring their biological safety.
Ensure your packaging meets standards with expert packaging validation. Trust us for reliable compliance every time. Packaging validation is a critical aspect of ensuring the safety and effectiveness of medical devices. It involves a comprehensive evaluation of packaging equipment, materials, and designs, as well as processing variables that impact the ability of a packaged device to meet its acceptance requirements. This process is essential for preserving the sterility of medical devices, protecting their functionality, and ensuring their biological safety.
Ensure your packaging meets standards with expert packaging validation. Trust us for reliable compliance every time. Packaging validation is a critical aspect of ensuring the safety and effectiveness of medical devices. It involves a comprehensive evaluation of packaging equipment, materials, and designs, as well as processing variables that impact the ability of a packaged device to meet its acceptance requirements. This process is essential for preserving the sterility of medical devices, protecting their functionality, and ensuring their biological safety.
We prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV and EU MDR. Clinical evaluation report (CER) summarizes and concludes the clinical evaluation of medical devices. Clinical evaluation is responsibility of the manufacturer and is a critical step in process of CE Marking. Many manufacturers struggle and find it tedious to comply with the requirements of CER.
We prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV and EU MDR. Clinical evaluation report (CER) summarizes and concludes the clinical evaluation of medical devices. Clinical evaluation is responsibility of the manufacturer and is a critical step in process of CE Marking. Many manufacturers struggle and find it tedious to comply with the requirements of CER.
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Compliance Trainings would provide training on various concepts like Class I, II and III devices, 510(k), Premarket Approval (PMA), IVD’s (In Vitro Diagnostics) and Current Good Manufacturing Practices (cGMP).
We are able to offer advice and support to medical device companies whatever their size or requirements, Our consultants are MDR specialists and are able to offer extensive, expert experience to medical device companies covering a range of subjects including software, sterilisation, animal tissue derivatives and blood derivatives.
A new interpretation of Medical Device Regulation (MDR) recently updated Article 54 (2)b has been forwarded by the Medical Device Coordination Group (MDCG). According to MDCG, there are certain criteria under which medical devices can be exempted from premarket clinical evaluation consultations to be held before an expert panel.
End-point security, a critical aspect of cybersecurity, involves securing end-user devices such as computers, smartphones, and tablets from cyber threats. As organizations increasingly adopt remote work models and digital transformation initiatives, the need for robust end-point security solutions has surged. These solutions protect against malware, ransomware, phishing attacks, and unauthorized access, ensuring the integrity and confidentiality of sensitive data. The global end-point security market is expected to experience substantial growth, with a projected CAGR of 8.5% from 2023 to 2030. This expansion will increase the market value from US$12.9 billion in 2023 to US$23.7 billion by the end of 2030. Key drivers include rising cyber threats, regulatory compliance requirements, and the growing adoption of cloud-based services.
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Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations. Need Help: Uk: +44- 7424810299 Email: sales@pepgra.com Whatsapp: +91 9884350006
Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations. Learn More: https://www.pepgra.com/device-manufacturers/ Need Help: Uk: +44- 7424810299 Email: sales@pepgra.com Whatsapp: +91 9884350006
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•For long, medical device regulations continued to remain stagnant till such time that the world was struck with the hip replacement and breast implant crisis. •The new EU-MDR and EU-IVDR brings in more stringent regulations, drastically modifying the way in which medical device manufacturers operate. The new regulations have also modified several device classes that were previously quite lenient into classes that now require strict review and evaluation. It also takes into its ambit accessories to medical devices that were previously unregulated. To Continue Reading : https://bit.ly/2WPk2Cw Medical Device : https://bit.ly/2QIdl17 Contact Us: Website : https://bit.ly/33Fwsye Email us: sales.cro@pepgra.com Whatsapp: +91 9884350006
Technical Files for medical devices in the UK are essential documents that contain comprehensive information about the design, manufacturing, and performance of a medical device. These files are a crucial part of the regulatory process and are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. It's important to note that the specific requirements for Technical Files can vary based on the classification of the medical device and any updates or changes in regulations. Consulting with our regulatory experts or agencies like the MHRA is advisable to ensure that your Technical File meets all necessary criteria.
Technical Files for medical devices in the UK are essential documents that contain comprehensive information about the design, manufacturing, and performance of a medical device. These files are a crucial part of the regulatory process and are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. It's important to note that the specific requirements for Technical Files can vary based on the classification of the medical device and any updates or changes in regulations. Consulting with our regulatory experts or agencies like the MHRA is advisable to ensure that your Technical File meets all necessary criteria.