Supporting your entire medical device journey into the US and EU markets

Our team provides expert services to ensure your medical device meets regulatory requirements for successful market launch and remains compliant throughout its lifecycle. We specialize in the EU and US markets, offering:

• Regulatory consulting services that guide you through the entire process of obtaining clearance or approval.
• Quality management services that include QMS development and implementation, risk management, and post-market surveillance.
• Clinical evaluation services that help demonstrate safety and effectiveness, including clinical trial design and CER preparation.

We take a hands-on approach to ensuring regulatory compliance and success in both EU and US markets by offering tailor-made services that fit your needs and budget. Contact us to learn how we can accompany you at every stage of your medical device journey.

Acting as your reliable in-house PRRC and QRAM

If you are an EU medical device manufacturer or importer, it is important to comply with the Medical Device Regulation (EU MDR) to ensure product safety and effectiveness. We support and strengthen yor team as your in-house PRRC (Person Responsible for Regulatory Compliance) and QRAM (Quality and Regulatory Affairs Manager). Our expert team provides the following services:

PRRC Services (according to MDR 2017/745, Article 15):

• Devices are checked for conformity with MDR requirements prior to release
• Technical documentation and the EU declaration of conformity are kept up-to-date
• Post-market surveillance obligations are fulfilled according to MDR
• Reporting obligations are managed reliably under the MDR

QRAM Services:

• Developing and implementing a Quality Management System (QMS) based on MDR and ISO 13485 requirements
• Providing training and support to your team to ensure everyone is aligned and in-tune with their responsibilities and duties
• Maintaining and overseeing QMS and regulatory processes to ensure compliance with MDR and local regulatory requirements

Maximizing market success with comprehensive regulatory due diligence and audit prep services

At CATALYST SCIENTIFIC, we offer comprehensive audit and due diligence services for medical device companies and venture capital investors. Our services involve assessing companies´ regulatory compliance to identify any potential risks that may impact their ability to comply with regulatory requirements. This process includes the review of a product´s development history, clinical evaluation, and risk management activities, followed by remediation planning and ongoing support to meet critical requirements and expectations.

For VCs: Engaging us for regulatory due diligence activities will give you a better understanding of regulatory risks and opportunities, allowing you to make more informed investment decisions.

For manufacturers: We understand the importance of optimal audit preparations and are committed to providing you with the highest level of confidence before audits by Notfied Bodies, EU regulatory authorities or the FDA. Contact us today to learn more about our audit and due diligence services.

Enabling you to successfully bring your medical device to the market

Our mission is to help start-up companies bring their medical devices to market, by providing strategic, regulatory, and quality management services. We offer efficient and tailored services at every stage of the development process, from concept to commercialization.

Our regulatory experts will help ensure that your device meets all necessary requirements. We can also develop a quality management system tailored to your specific device and company needs.

As part of our support, we can assist in developing a commercialization strategy. This includes identifying potential markets, developing marketing strategies, and building relationships with key stakeholders.

We are passionate about supporting innovation in the medical device industry and helping turn ideas into great products with a positive patient impact. Contact us today to learn more about how we can support your start-up journey.