We have experienced ISO 13485 consultants that can help your medical device manufacturer become compliant with the latest industry standards.ISO 13485 is a quality management system for a medical device manufacturing organization, which is used to control the various processes...

Explore the intricacies of CE certification for contact lenses. Learn about the standards and processes in this detailed guide. Obtaining CE Certification for contact lenses is not just a regulatory requirement; it’s a strategic investment in the safety, quality, and success o...

Gain global market access with MDSAP Certification, your key to streamlined compliance and international regulatory acceptance. In today’s world, selling your products globally can make your business successful. But, understanding all the rules and regulations in different cou...

Ensure your medical devices meet European standards with CE Marking. Stay compliant and gain market access across the EU. Maven is a regulatory consultancy providing one-stop solution for the CE marking of your medical devices, providing overall support with technical document...

Dive into global medical device labeling: Symbology for Safety ensures universal understanding across diverse cultures. Explore now! This guideline pertains to symbols employed across various medical devices sold worldwide, necessitating compliance with diverse regulatory stan...

Understanding and complying with country registration requirements is essential for successful market entry and ensuring the safety and efficacy of medical devices. Each country may have specific requirements, so it’s essential to consult the respective regulatory authority’s...

In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR). Navigating the regulatory landscape of medical devices i...

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 Pe...

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 equip...

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 device...

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...

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 cl...

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, certifica...

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 organizationa...

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 guidelin...

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...

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 He...

In the UK, CE Mark 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 th...

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...

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 dem...

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 literat...

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...