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Navigating the regulatory landscape of medical devices in the European Union demands a thorough understanding of both the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR). While these regulations share commonalities, such as risk-based classification and conformity assessment, differences in scope, implementation dates, and the level of notified body involvement necessitate careful consideration from manufacturers. Adhering to these regulations is not only a legal requirement but a commitment to ensuring the safety and efficacy of medical devices for the well-being of patients.

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Delve into IVDR's Summary of Safety and Performance for crucial insights and compliance essentials. Stay informed with our concise guide. The world of in vitro diagnostics is all about accuracy and reliability. EU IVDR includes a requirement to write a Summary of Safety and Performance (SSP) for Class C and D IVDs. The goal is to emphasise transparency and provide adequate public access to summarise the data on safety and performance to patients and intended users, which includes both professionals and lay people where applicable.

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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.

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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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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.

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Experience seamless quality control with our Integrated Quality Management System. Elevate efficiency and productivity effortlessly. The QMS requirements of the Canadian Medical Devices Regulations are included in the MDSAP. A document outlining the current good manufacturing practices requirements is the FDA 21 CFR Part 820, often known as the Quality System Regulation. A MAVEN integrated quality management system complies not only with ISO 13485, but additional medical device regulatory requirements in many other markets.

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To achieve and sustain excellence, a company needs a good quality control system. We provide Internal Quality Audit to helps organizations. Internal Quality audits are typically performed at predefined time intervals as per the audit plan and ensure that the institution has clearly defined internal system monitoring procedures linked to effective action. The audits are unbiased and require cross-functionality of departments.

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Maven Profcon Services LLP is a medical device consulting regulatory company provides regulatory guidance to medical device manufacturers in Ecuador. We help our clients by providing turnkey project services such as quality system accomplishment, training, licensing, certification, and regulatory approval.

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Take a premium advantage of MAVEN's Premium Organizational Management Services. These services are only for clients who are completely invested in making their plant highly compliant and are ready to consider regulatory compliance an important parameter for their organizational success and make necessary resources available to achieve the same. Maven provide the best solution to get US FDA 510K Approval for medical equipment.

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The newly proposed MDCG guidelines are a valuable resource for manufacturers (of products without an intended medical purpose), notified bodies, and stakeholders navigating the intricate landscape of medical device regulatory standards. A comprehensive review of these guidelines is crucial to maintain the safety and efficacy of medical devices in the market. In conclusion, when embracing these guidelines, it is crucial to understand the guiding principles and consider the similarities with medical devices.

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We provide best AMC service where we take complete charge of ensuring regulatory compliance of all certifications held by the manufacturer. We acknowledge the limitations faced by such organizations and have specially curated our Annual Maintenance Contract Services, where we take complete charge of ensuring regulatory compliances of all certifications held by the manufacturer. These services include maintenance and update of quality management system, planning and performing Internal Quality Audits (IQA) and Management review meetings (MRM), Mock audits, Support during audits, closure of non-conformities and observations for both, internal and external audits. We also ensure that their technical documentation is kept up-to-date and in compliance to the regulation.

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Classification of Medical Devices in Malaysia

Medical devices in Malaysia are classified by CDSCO, Central Licensing Authority. Medical device other than in-vitro diagnostic medical devices are classified on basis of: Risk, Intended purpose, Duration of contact, Invasiveness- non-invasive, invasive with respect of body orifice, surgically invasive.

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A Clinical Evaluation Plan is a document that outlines the systematic process of assessing the safety and performance of a medical device. It is a crucial component in the medical device industry as it ensures that devices meet the necessary regulatory requirements and provide optimal patient safety.

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The CE mark is of utmost importance in the European market, and understanding its intricacies is crucial for success. In this fast-paced and highly regulated industry, keeping up with the latest requirements and standards can be a challenge. That’s where we come in. Our team of experts specializes in helping medical device companies navigate the complex world of CE marking.

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The interrelationship between EN ISO 14971:2019/A11:2021 and the General Safety and Performance Requirements of Regulation holds great significance for device manufacturers in the EU. Collaborating with regulatory experts and notified bodies can further aid manufacturers in traversing these requirements adeptly and achieving compliance with plan.

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However, the new medical devices regulations (EU MDR) contain important improvements including a much larger EUDAMED database. The new EUDAMED will be multipurpose. It will function as a registration system, a collaborative system, a notification system, a dissemination system (open to the public), and will be interoperable.

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A clinical development plan is a subpart of a clinical evaluation plan which aims at the devices which are going for clinical evaluation or the devices undergoing clinical investigations in the future. It is an important tool that helps the manufacturer to establish the extent of the clinical evaluation planning for their medical devices.