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...

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 procedur...

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...

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...

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 o...

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 tr...

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...

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...

It has been said that European Medical Device Regulations is the most significant change to the regulatory framework in the medical device industry since CE Marking was introduced in 1993. Get detailed information, rules, and regulation about European Medical Devices. We have...

The risk management standard ISO 14971:2019 is the Holy Bible for medical device risk management. As elegant as it has been presented on its own, one could consider it as ISO’s tip of the hat to acknowledge Regulation (EU) 2017/745, the EU MDR. As a successor to ISO 14971:2007...

We help you find the valid UK Responsible Person who is legally placed in UK market and help you getting UKCA mark. Definition of UK responsible person as per UK MDR 2019 is “ a person established in the United Kingdom who acts on behalf of a manufacturer established outside t...

The MHRA Registration database contains manufacturer name, address, MHRA reference (account) number, all the devices registered by GMDN term. MHRA Registration must be renewed one year after your registration application or confirmation was made and every two years after this...

Our consultancy helps you in establishing your products in various countries with help of our experienced regulatory consultants. The content of the Technical File for UKCA Mark is similar to that of Technical documentation prepared for EU MDR/IVDR with only minor differences...

Get the EUDAMED registration done for IVD based on the regulations of EU 2017/746. We assist you get the CE for In-vitro Diagnostic Device CE Marking Service covering General IVDs, Self-testing IVDs and all other classes of devices ensures that quality certification is provide...

Maven helps you to design a Stability Studies of Medical Devices Plan and reduce errors. The purpose of the Stability Studies of Medical Devices is to give information on how the quality of medical devices does not vary with time under the influence of a variety of environment...

Get your Design History File planned and approval for your medical devices in Vietnam, Malaysia, Hong Kong and Thailand. Get complete assistance in creating DHF as per the requirements of ISO 13485:2016, EU MDR 2017/745 and EU IVDR 2017/746.A Design History File is a complex d...

We help you get done medical devices usability testing. We provide medical device usability testing and usability engineering services in Vietnam, Malaysia, Hong Kong and Thailand. Performing Medical Device Usability testing helps the manufacturer to assess and mitigate risks...

Get the latest regulatory guidelines on Instruction for use and label as per the ISO 15223, ISO 20417 and EN 15986 in Vietnam, Malaysia, Hong Kong and Thailand. Medical device symbols should be represented in all medical device labelling and packaging material. Medical device...

Get your Medical Device Testing done, We help you to provide Bio-compability testing, performance testing, Clinical and pre-clinical testing and Chemical Analysis for your Medical Devices in Vietnam, Malaysia, Hong Kong and Thailand. Medical device testing evaluates various as...

The summary of safety and clinical performance (SSCP) shall be laid out with an objective of it being easy for the intended user to interpret and, if relevant, to the patient. It shall be made available to the public via Eudamed. Along with all the other technical documents, t...

List Of Applicable Standards (LOAS) is a document that provides requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for purpose or intended use. Before selling a medical...

Under the EU MDR (EU 2017/745) and IVDR (EU 2017/746) , all medical devices must have an Instructions for Use (IFU) that describes the device’s intended purpose, use, proper maintenance, and potential risks. The IFU must also include detailed information on how to safely use t...