Description

Camden Surgical Vascular Pack is a meticulously designed single-use operative procedure pack (SOPP) tailored for specific surgical applications. These packs are crafted to streamline surgical procedures by providing all necessary components in one comprehensive, sterile package.

Key Features

• Convenience and Efficiency: Each pack is assembled to include all required items for a particular surgical procedure, enhancing operational efficiency and reducing preparation time.
• Sterility Assurance: The single-use nature ensures sterility, minimizing the risk of contamination and infection.

Instructions for Use

Each component within the pack comes with its own Instructions for Use (IFU), as provided by the original manufacturer. In cases where the IFU is modified by Camden Surgical, the company assumes full responsibility for the component, adhering to relevant conformity assessment procedures.

Implantable Medical Devices

If the pack includes implantable medical devices, it is equipped with essential patient information materials, such as implant cards and information leaflets. These are available in printed or electronic form, with certain exceptions for items like sutures and staples.

Electronic Instructions

Electronic IFUs are available for professional users, enhancing accessibility and convenience. However, these are not provided for packs intended for public supply, ensuring compliance with regulatory standards.

Regulatory Compliance

Camden Surgical Vascular Pack complies with stringent regulatory requirements concerning labelling, documentation, and conformity assessment. Sponsors are tasked with maintaining ongoing compliance and must furnish evidence of market authorisation when necessary.

Commitment to Quality

Camden Surgical's commitment to quality and regulatory adherence ensures that each surgical pack meets the highest standards, providing healthcare professionals with reliable and effective tools for successful surgical outcomes.