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 transition period between the Medical Device Directive (MDD) and the In-Vitro Device Directive (IVDD) and the new EU MDR and EU IVDR has changed due to the COVID-19 public health crisis; however, compliance remains a must. The new directives include increased clinical requirements, reclassified devices and changes to notified bodies.
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 will provide the necessary strategic planning to ensure you meet all applicable deadlines.
It was established in 2014 with its experienced staff with many annual audits in the Medical Device sector, Medical device product and system certification Chief Auditor, Product development, business development specialist titles.
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 and our 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, anticipate 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 and with guaranteed compatibility.
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, Chief Auditor, Product and Clinical Evaluation.