Medical Devices
Medical devices play a crucial role in healthcare, designed to diagnose, treat, prevent diseases, or modify a physiological process without pharmacological action. At Pharmanager Development, we apply our expertise to ensure their regulatory compliance and success in the market.
Regulatory Status and Class Evaluation
We analyze the characteristics of your product to determine if it is classified as a medical device and define its class (I, IIa, IIb, III) based on its risk level.
Project Feasibility Evaluation
We conduct a thorough analysis of the regulatory and technical aspects to determine if your product meets the required criteria for market entry. This includes evaluating compliance with relevant standards, identifying potential challenges, and proposing solutions to ensure your product can successfully navigate the regulatory landscape.
Accompagnement scientifique et évaluation clinique
Nous vous guidons dans la réalisation des études cliniques nécessaires et dans l’interprétation des résultats pour répondre aux exigences du règlement européen dispositifs médicaux.
Scientific Support and Clinical Evaluation
We guide you in conducting the necessary clinical studies and interpreting the results to meet the requirements of the European Medical Devices Regulation. Our support ensures that your clinical data is robust, compliant, and effectively addresses regulatory demands for market approval.
Choosing Compliance Evaluation Procedures
We identify the most suitable procedure to obtain CE certification for medical devices, in collaboration with notified bodies. This ensures that the product undergoes the correct evaluation process, meeting all necessary regulatory requirements for market approval.
Choosing Compliance Evaluation Procedure
We assist in drafting a detailed technical specification to guide the development of your product while ensuring compliance with European standards. This ensures that the product meets all regulatory requirements and is ready for the certification process.
Pharmanager Development assists you in:
We guide our clients through every key stage of their medical device lifecycle, from the initial design and development phase to market launch.
Our approach integrates in-depth expertise to meet strict regulatory requirements, both European and international, ensuring product compliance and safety.
We work closely with our partners to optimize regulatory strategies, prepare the necessary technical documentation, and ensure that every step meets the highest standards.
With our support, our clients can navigate the complexities of the regulatory framework while maximizing their chances of success in global markets.
Our answers to your questions
What is a 510(k) submission, and when is it required?
A 510(k) submission is a premarket notification required by the U.S. Food and Drug Administration (FDA) for certain medical devices. It demonstrates that the device is substantially equivalent to a legally marketed device (predicate) not subject to premarket approval. This process allows the device to be marketed in the United States. A 510(k) is typically required when introducing a new device to the market or making significant modifications to an existing device that could affect its safety or effectiveness.
What are the different classes of medical devices, and how are they regulated?
Medical devices are classified into three categories based on the level of control necessary to ensure safety and effectiveness:
– Class I: Low-risk devices subject to general controls. Examples include dental floss.
– Class II: Moderate-risk devices requiring general and special controls, often cleared through the 510(k) process. Examples include diagnostic tests and hearing aids.
– Class III: High-risk devices that support or sustain life, requiring premarket approval (PMA). Examples include implantable pacemakers.
The regulatory pathway depends on the device’s classification, with Class I devices subject to the least regulatory control and Class III to the most stringent.
How can medical device regulatory consulting help my company
Medical device regulatory consulting services provide expertise and support in understanding regulatory requirements, developing compliance strategies, preparing regulatory submissions, implementing quality management systems (QMS), and resolving compliance issues. Consultants assist in navigating complex regulatory landscapes, ensuring that products meet all necessary standards for market approval.
What is the EU Medical Device Regulation (MDR), and how does it impact manufacturers?
The EU Medical Device Regulation (MDR) is a set of regulations that replaced the EU’s original Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC). The MDR came into force on 25 May 2017 and became applicable on 26 May 2021. It imposes stricter requirements on medical device manufacturers, including more rigorous clinical evaluations, increased transparency through the European database on medical devices (EUDAMED), and enhanced post-market surveillance. Manufacturers must ensure compliance with these regulations to market devices in the European Union.