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Medical Devices Registration: A Guide for Bangladesh

Get insights into medical devices registration in Bangladesh: regulations, process, and more. Your go-to for navigating registration require

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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Experience seamless quality control with our Integrated Quality Management System. Elevate efficiency and productivity effortlessly.

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.

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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Best Turnkey Project Consultancy for Medical and IVD Devices in Bangladesh

Maven Profcon Services LLP is a medical device consulting regulatory company provides regulatory guidance to medical device manufacturers in

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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Best regulatory consultant for US FDA 510K Approval in USA

Maven provide the best solution to get US FDA 510K Approval for medical equipment in Vietnam, Thailand, Malaysia and Hong Kong.

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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Deciphering MDCG Rules: Annex XVI Insights Revealed!

Crack the Code: Annex XVI MDCG Rules Demystified! Your key to compliance insights. Dive into the intricacies.

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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Classification of Medical Devices as per CDSCO in India

Detailed classification of Medical Devices and In-vitro Diagnostic Medical Devices in India. Get depth knowledge of notified and non-notifie

Medical devices in UK 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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Best Annual Maintenance Contract (AMC) Service Provider in India, AMC Services for Medical and IVD Devices globally

We provide best AMC service where we take complete charge of ensuring regulatory compliances of all certifications held by the manufacturer

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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Medical Device Technical File (MDR) as per the requirement of MDR 745/2017 in United States

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

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. Consulting with our regulatory experts or agencies like the MHRA is advisable to ensure that your Technical File meets all necessary criteria.

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Clinical Evaluation (CE) Solution Provider for Medical Devices in India, EUDAMED Registration in Belgium

We are the pioneer in providing CE Marking and Certification regulatorly solution in Europe. Get Clinical Evalution for your Medical Devices

In the UK, CE for Medical Devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has introduced its own regulatory system for medical devices, which includes the UK Conformity Assessed (UKCA) mark. To place a medical device on the UK market, manufacturers must adhere to the UK regulations and requirements, including conformity assessments.

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Clinical Evaluation Reports for Medical Device Manufacturer

We prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV and EU MDR.

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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Demonstration of Equivalence for Medical Devices Manufacturer

Maven Profcon helps device makers demonstrate EU MDR 2017/745, MEDDEV 2.7.1 rev. 4 & MDCG 2020-5 compliance.

Demonstration of Equivalence shall be performed as per the requirement of Part A, section 3 of Annex XIV of EU-MDR. The MDR (Annex XIV, Part A) establishes that, in order to demonstrate equivalence in relation to other devices, three characteristics must be considered when demonstrating equivalence: technical, biological, and clinical. These characteristics shall be investigated and differences between devices should be disclosed.

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Prove Clinical Safety and Performance of your device with Literature Search Protocols and Report

We help you prepare literature search protocols using non-biased methodology such as PICO. Prepare Literature Search Report for the approval

Systematic Literature Search Protocols and Report is a key part of clinical evaluation and an alternative pathway to clinical trials in order to prove the clinical safety and performance of your device. It’s a tedious process and involves numerous hours of work. In the literature search the manufacturer of device collects scientific articles to document state of art, safety and performance data and clinical benefits of the device.

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Perfect Clinical Evaluation Plan Solution Provider in Malta, Clinical Evaluation as per the MEDDEV 2.7/1 and EUMDR

We help you in preparing Clinical Evaluation Plan as per the requirement of MEDDEV 2.7/1 and EU MDR in malta, Vietnam and United Arab Emirat

A clinical evaluation plan is a strategic plan that defines the clinical evaluation process required by MEDDEV 2.7/1 rev 4 and EU MDR article 61 and Annex XIV Part A. The clinical evaluation plan acts as planning document for your clinical evaluation and all the activities of Clinical Evaluation are carried out as per the Clinical Evaluation Plan.