About Us

Who Are We?

Whether you are an emerging startup with a new device or an established company with a portfolio of products, MedENvolve Consultancy has a solution to meet your needs.

With decades of industry experience, regulatory and compliance expertise and a suite of scalable solutions, we will help you develop your product in compliance with worldwide regulatory requirements.

The EU MDR and EU IVDR have replaced the Medical Device Directive (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD). The transition periods were extended, first because of the COVID-19 pandemic and later by further amending regulations; however, compliance remains a must. The MDR and IVDR bring increased clinical evidence requirements, reclassified devices and changes for notified bodies. Which dates and requirements apply to you depends on your device’s class and certification status, so they need to be assessed product by product.

Partner with a global regulatory, compliance and quality expert to successfully implement EU MDR and/or EU IVDR. With decades of European regulatory experience, MedENvolve Consultancy helps you identify the deadlines that apply to your products and build a strategic plan around them.

MedENvolve was established in 2014 by an experienced team with many annual audits in the medical device sector, holding the titles of medical device product and system certification lead auditor, product development and business development specialist.

We offer real and permanent solutions to the needs and demands of our manufacturers with our R&D, production, QA/RA expertise and notified body experience, together with adequate technical equipment and trained personnel.

PRODUCT DEVELOPMENT

Our consulting services play a strategic role in product development from day one. Our in-house technical and scientific experts provide valuable input to help you meet your business needs, performing quality and regulatory work together while ensuring compliance. When you are ready, we will be there to strategize and deliver.

Several factors such as device class, availability of predicate devices and technology drive the path to market approval for medical devices.

With our regulatory strategy service, you will know your product's device classification, predicate devices if any, and the applicability of the following to your products:

Performance testing requirements
International performance standards
Global requirements for market entry
Contact one of our experts to move your product through the development process more efficiently, with the compliance requirements planned for your specific product.

REGULATORY STRATEGY

The class of a device, the availability of predecessor devices and the technology all influence medical device authorization or licensing. With MedENvolve Consultancy on your side, you will have a clear understanding of what regulators want to see in your application. We also advise on the following topics:

Performance testing requirements
International performance standards
Global requirements for market entry

QMS INSTALLATION

Quality Management System (QMS) challenges are not limited to start-ups. We will help you implement a compliant, easy to implement, integrated and customizable quality management system.

POST-MARKET SURVEILLANCE (PMS)

MedENvolve Consultancy will take care of post-market surveillance and vigilance reporting activities.

OUR DIFFERENCE

Customer Satisfaction

We are here to provide real and lasting solutions with our experienced staff who are experts in the medical device industry and have 10 years of experience in production, lead auditing, product and clinical evaluation.

Years of Experience: 20+
Satisfied Customers: 240+
Successful Projects: 2000+
Company Consultancy: 25+