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Technical-File-Template-Medical-Device

SSCP Template

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SSCP-Template

Price: $600

SSCP is a vital requirement mandated by the European Union Medical Device Regulation (EU-MDR) 2017/745 specifically for implantable and Class-III devices, this template is prepared in strict accordance with the guidelines set forth in MDCG 2019-9. It serves as a repository of essential information related to the safety and performance of the device. It is designed to cater to the needs of intended users, including healthcare professionals and patients, by providing clear and concise details regarding the device’s characteristics, functions, and usage instructions.

Aligned with regulatory standards, this documentation ensures compliance with EU-MDR requirements, thereby facilitating the regulatory approval process for implantable and Class-III devices. By adhering to the guidelines outlined in MDCG 2019-9, manufacturers can demonstrate their commitment to delivering safe and effective medical devices to the market.

This template is designed by highly experienced professionals for all medical device companies. Click below to get a preview of this template.

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