CE Marking Medical Devices
The CE marking of medical devices and in vitro diagnostic devices (IVDs) is a requirement of EU regulations (EU 2017/745
Patient Guard as a medical device regulatory consultancy prides itself on its team of regulatory professionals, each possessing extensive experience and expertise in medical device and IVD regulations. Our Medical Device consultants have diverse backgrounds, including regulatory affairs, quality assurance, clinical affairs, and product development, allowing us to offer comprehensive support across all aspects of regulatory compliance. With years of experience navigating the intricacies of global regulatory frameworks, including the UK, EU, and FDA regulations, our team is well-equipped to address the unique needs and challenges of each client.
At Patient Guard, we offer a wide range of medical device regulatory consultancy services tailored to meet the specific needs of manufacturers, distributors, and stakeholders. Our services include:
Our comprehensive services are designed to streamline the regulatory process, minimize compliance risks, and accelerate market access for your medical devices and IVD products.
Patient Guard specializes in navigating the complexities of regulatory frameworks in key markets, including the UK, EU, and the United States. Our consultants stay abreast of the latest regulatory updates and changes, ensuring that our clients remain compliant with applicable regulations and standards. Whether you’re seeking guidance on UK Medical Device Regulations 2002, EU MDR 2017/745, EU IVDR 2017/746, or FDA regulations, Patient Guard has the expertise and experience to support your regulatory compliance efforts effectively.
We understand that each client has unique regulatory requirements and challenges. That’s why Patient Guard offers tailored solutions designed to address the specific needs and objectives of your organization. Whether you’re a small start-up or a multinational corporation, we work closely with you to develop customized strategies that align with your business goals and regulatory obligations. Our flexible approach ensures that you receive the support and guidance you need to achieve regulatory compliance and market success.
Choosing an established consultancy like Patient Guard offers several advantages over using an individual consultant. Here’s why:
Patient Guard provides access to a team of experts with diverse backgrounds and specialties, ensuring comprehensive support across all aspects of regulatory compliance. With a collective wealth of experience and expertise, we offer insights and guidance that an individual consultant may not be able to provide.
Patient Guard has a proven track record of success and a reputation for excellence in the industry. By partnering with us, you can trust that you’re working with a stable and reliable partner committed to your success.
Patient Guard offers scalable and flexible solutions to meet your evolving needs. Whether you require ongoing support or assistance with specific projects, we can adapt our services to accommodate your requirements effectively.
Our consultants bring specialized knowledge and expertise to augment your in-house capabilities, ensuring that you have access to the skills and resources needed to navigate complex regulatory requirements.
Partnering with a consultancy allows you to optimize your resources more effectively. Instead of hiring additional full-time staff or burdening existing team members with additional responsibilities, you can rely on Patient Guard to provide the expertise and support you need on a flexible basis.
Patient Guard provides invaluable regulatory guidance and best practices based on industry standards and regulatory requirements. By leveraging our expertise, you can ensure that your organization stays ahead of regulatory changes and adopts best practices for compliance and quality assurance.
Utilizing consultancy services can offer cost savings compared to maintaining a large in-house regulatory and quality assurance team. With Patient Guard, you pay for the services you need when you need them, avoiding the overhead costs associated with full-time employees.
Patient Guard is committed to helping manufacturers, distributors, and stakeholders navigate the complex regulatory landscape of medical devices and IVDs. With our extensive experience, comprehensive services, and commitment to excellence, we are your trusted partner in achieving regulatory compliance and market success. Contact Patient Guard today to learn more about how our consultancy services can benefit your organization.
Tracey Slater, Cormed
The CE marking of medical devices and in vitro diagnostic devices (IVDs) is a requirement of EU regulations (EU 2017/745
When developing a new and exciting product it can be hard to know if it might fall under specific regulations.
A medical device technical file is a concise set of documents created by a manufacturer to explain the performance and
In the EU Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring),
Patient Guard Limited:
Lancaster House,
Amy Johnson Way,
Blackpool, Lancashire FY4 2RP
Patient Guard Europe UG:
Hauffstr. 41, 73765 Neuhausen,
Deutschland / Germany
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