Medical Devices Consulting
The best way to ensure that medical devices meet international regulatory requirements is through a consulting service.
Our services
We offer the best services in medical devices consulting.
CE marking
of medical devices
Our experts will explain you how to make software development, usability and validation plans.
Regulatory
strategy
Commercialization in other markets. Product registration. Entry strategies in third countries.
ISO 13485 quality management systems
Clinical assessment plan and performance evaluation. We seek the best clinical strategy.
Regulatory strategies
Medical device consulting also encompasses the development of regulatory strategies. This includes assistance in identifying the product’s risk class and designing the most appropriate strategy to obtain the clinical evidence necessary to achieve CE marking. The first step is to ensure that the manufactured product is indeed a medical device. Then, we proceed to classify it according to the level of risk.
To gather clinical evidence, different paths can be followed, including clinical research, entry strategy planning, and the development of marketing materials that comply with advertising regulations. Consultants can offer advice on how to position a product in a competitive market, manage intellectual property, and comply with advertising and promotion regulations.
Regulatory strategies
Medical device consulting also encompasses the development of regulatory strategies. This includes assistance in identifying the risk class of the product and designing the most appropriate strategy to obtain the clinical evidence necessary to achieve CE marking. The first step is to ensure that the manufactured product is indeed a medical device. Then, we proceed to the classification according to the level of risk.
To gather clinical evidence, different paths can be followed, including clinical research, entry strategy planning, and the development of marketing materials that comply with advertising regulations. Consultants can offer advice on how to position a product in a competitive market, how to manage intellectual property, and how to comply with regulations related to advertising and promotion.
Management risk management
Risk management is an essential component of medical device consulting. Medical devices must be safe for patients and users, which involves identifying, assessing and mitigating the risks associated with their use. This entire process must be carried out under the percepts of ISO 14971.
Our consultants help companies develop risk management plans, which include hazard identification, probability and severity analysis, and implementation of controls to minimize risks and residual risk analysis. This process is critical not only for regulatory compliance, but also to ensure consumer confidence and company reputation.
Management risk management
Risk management is an essential component of medical device consulting. Medical devices must be safe for patients and users, which involves identifying, assessing and mitigating the risks associated with their use. This entire process must be carried out under the percepts of ISO 14971.
Our consultants help companies develop risk management plans, which include hazard identification, probability and severity analysis, and implementation of controls to minimize risks and residual risk analysis. This process is critical not only for regulatory compliance, but also to ensure consumer confidence and company reputation.
Documentation technical
If a medical device manufacturer wants to successfully resolve the evaluation of its product to certify compliance with the regulation, it is necessary to present in an orderly manner all the documentary evidence that ensures compliance with the requirements. Therefore, the preparation and maintenance of technical documentation is an indispensable requirement for regulatory compliance.
This documentation includes a detailed product description, design data, clinical research results, and compliance testing, among others. Medical device consulting provides support in the preparation of this documentation, ensuring that it is complete, accurate and compliant with regulatory requirements. This is crucial for the conformity assessment process and obtaining CE markings or FDA approvals.
Documentation technical
If a medical device manufacturer wants to successfully resolve the evaluation of its product to certify compliance with the regulation, it is necessary to present in an orderly manner all the documentary evidence that ensures compliance with the requirements. Therefore, the preparation and maintenance of technical documentation is an indispensable requirement for regulatory compliance.
This documentation includes a detailed product description, design data, clinical research results, and compliance testing, among others. Medical device consulting provides support in the preparation of this documentation, ensuring that it is complete, accurate and compliant with regulatory requirements. This is crucial for the conformity assessment process and obtaining CE markings or FDA approvals.
Research clinics
In some cases where the degree of risk to the patient requires it, it is necessary to conduct clinical investigations to demonstrate the clinical benefit of the product. In other cases, manufacturers wish to confirm intended use through research. In summary, clinical investigations are essential to demonstrate the safety and efficacy of medical devices, especially for those of higher risk.
In many cases, research must be authorized by the Spanish Agency for Medicines and Health Products (AEMPS). Having consultants specialized in this area can help companies design and prepare the application for authorization by the AEMPS. In addition, they can assist in the preparation of clinical reports required for regulatory applications.
Research clinics
In some cases where the degree of risk to the patient requires it, it is necessary to conduct clinical investigations to demonstrate the clinical benefit of the product. In other cases, manufacturers wish to confirm intended use through research. In summary, clinical investigations are essential to demonstrate the safety and efficacy of medical devices, especially for those of higher risk.
In many cases, research must be authorized by the Spanish Agency for Medicines and Health Products (AEMPS). Having consultants specialized in this area can help companies design and prepare the application for authorization by the AEMPS. In addition, they can assist in the preparation of clinical reports required for regulatory applications.
Behind behind the success
In EpisKey Medical Consulting we work with a team of specialists with extensive experience in medical devices, and eager to collaborate. We carry out projects that deal with obtaining the distribution license for medical devices, applying for the CE marking required for a medical device to be marketed in the European Union or training our clients to act as Technical Responsible for their product.
We know exactly how to classify your medical devices according to the new regulations and we are used to working in a changing and technological environment. We offer solutions to the medical devices industry adapted to your situation: permits, authorizations, regulations, certifications, etc.
What is consulting?
of medical devices?
The field of medical device consulting encompasses a range of specialized services provided to companies involved in the development, manufacture or distribution of medical devices. These services include regulatory guidance, risk management, technical documentation, clinical investigations and strategies to address regulatory compliance, among others. Our consultants play a vital role as intermediaries between companies and regulatory authorities, ensuring that products meet all legal requirements before going to market.
Standards and regulations
One of the most crucial aspects of medical device consulting is regulatory compliance. In Europe, medical devices must comply with the Medical Devices Regulation (MDR 2017/745) or the In Vitro Diagnostic Regulation (IVDR 2017/746), depending on their nature. These regulations set strict requirements for conformity assessment, technical documentation and post-market surveillance. Our consultants help companies interpret and apply these regulations, ensuring that their products can be marketed without problems.
In other markets, such as the United States, the Food and Drug Administration (FDA) is the primary regulatory authority. Consulting in this context involves guiding companies through the 510(k) clearance or premarket approval (PMA) application process, ensuring that products meet the required safety and efficacy standards.
We also assist our clients in developing quality management systems that are in compliance with CRF 21.820.
Medical device consulting is an essential tool for companies seeking to ensure the success of their products in a highly regulated environment.
From regulatory compliance to risk management, technical documentation, clinical trials and market strategies, our consultants offer a comprehensive approach that helps medical device manufacturing companies overcome challenges and maximize the potential of their products in the global marketplace.
Acknowledgments
Episkey Medical Consulting International Consultancy Award
We attended the forum on innovation and digital transformation in healthcare
Testimonials
Having a consultant help us with CE marking saved us time and gave us a better understanding of the process.
Isabel told us that we were going to go hand in hand and we did, they were always available and always answered our questions.
Regulation is always a necessary evil and after bumping up against it several times, Episkey helped us understand what we needed and move forward quickly.
projects
%
success
CE marked
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