Untitled

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.

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.

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.

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.

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.

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.

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.

We deal with the aspects of professional CE Marking Consultancy for medical devices. We Are A Premium Regulatory Compliance Solutions Provider For Medical Devices/IVDs. CE Marking for Medical Device Service covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes spanning a diverse range of indications.

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.

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.

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.

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.