Regulatory Compliance Services

Regulatory Affairs Expertise

With over 15 years of experience in regulatory affairs, we offer:

• Technical Documentation Review: Expertise in reviewing documentation in accordance with IVDR and MDR requirements.
• Global Registration Support: Assistance with registration processes worldwide, focusing on Europe, USA (including 510(k) submissions), and Canada.
• Regulatory Strategy Development: Crafting tailored strategies to meet diverse regulatory requirements.

Our goal is to streamline your path to market while ensuring full compliance.

Person Responsible for Regulatory Compliance (PRRC)

Under EU MDR and IVDR Article 15 and MDCG 2019-7, micro and small enterprises are not mandated to have a PRRC within their organization but must have one permanently and continuously at their disposal.

Our PRRC Services include:

• Acting as your designated PRRC, ensuring continuous compliance oversight.
• Monitoring conformity of devices with quality management systems.
• Ensuring technical documentation and declarations of conformity are up-to-date.
• Overseeing post-market surveillance and vigilance reporting.

Leverage our expertise to fulfill your PRRC obligations efficiently

European Authorised Representative (EAR)

For manufacturers without a registered place of business in the EU, appointing an European Authorised Representative (EAR) is a legal requirement under MDR and IVDR Article 11.

Our EAR Services Offer:

• Serving as your official liaison with EU regulatory authorities.
• Ensuring compliance with EU directives and regulations.
• Maintaining and providing access to technical documentation.
• Assisting with incident reporting and corrective actions.

Partner with us to navigate EU regulatory landscapes seamlessly.