Prime Dental Products Pvt. Ltd.

• Product conformity: Ensuring that the product conforms to the company's quality management system (QMS) • Technical documentation: Ensuring that technical documentation and the EU declaration of conformity are up to date. • Post-market surveillance: Overseeing post-market surveillance (PMS) obligations. • Reporting: Ensuring that the company fulfills its reporting obligations. • Regulatory changes: Staying updated on regulatory changes.

• Post-market surveillance: Overseeing post-market surveillance (PMS) obligations. • Reporting: Ensuring that the company fulfills its reporting obligations. • International standards: Ensuring compliance with international standards and their current status. • Annex XV statement: Issuing the Annex XV statement for investigational devices. • Backup PRRC for ensuring the company’s compliance with EUMDR.