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Gradient Ocean

Device-Compliance provides comprehensive regulatory services, including authoring and updating Safety Data Sheets (SDS) to meet international standards, developing and maintaining Quality Management Systems (QMS), and ensuring compliance with EUDAMED, FDA, USDA, and DEA regulations. Services include chemical classification, training, audits, and regulatory registrations, helping businesses maintain safety, quality, and regulatory compliance across various industries.

Safety Data Sheets (SDS) Services:

  • Authoring and updating SDSs to ensure compliance with current regulations.

  • Ensuring that SDSs comply with various international regulations such as OSHA’s Hazard Communication Standard (HCS), REACH, GHS, WHMIS (Canada), and others. Providing compliance checks for existing SDSs.

  • Classifying chemicals according to GHS criteria and other relevant regulations.

  • Document Management: Maintaining and managing SDS databases.

  • Training and Education: Conducting training sessions for employees on how to read and understand SDSs.

  • Ensuring comprehensive, compliant Safety Data Sheets that provide essential information for the safe handling and use of chemical substances.

EUDAMED Compliance Services:

  • Assisting with Actors Registration in the EUDAMED database.

  • Ensuring compliance with Unique Device Identification (UDI) and device registration requirements.

  • Managing interactions with Notified Bodies and certificates.

FDA Related Services:

  • Acting as the FDA authorized agent for foreign companies.

  • Assisting with device classification and listing.

  • Handling establishment registration and renewals.

  • Obtaining Certificates of Foreign Government, 801, and 802 export certifications.

  • Responding to and avoiding FDA Form 483 observations.

  • Ensuring UDI compliance and providing FDA audit compliance support.

  • Managing California FDB license registration and renewals.

Quality Management System (QMS) Services:

  • Development, maintenance, improvement, and support of certified QMS.

  • Conducting gap analyses and quality supplier audits.

  • Selection and interpretation of US and international QMS requirements.

  • Assessing product safety standards and developing test protocols.

  • Conducting audits for ISO 13485, MDSAP, and IVDR.

USDA Related Services:

  • Assisting with facility registration with the USDA.

  • Handling the application and management of import permits.

  • Providing pre and post-audit assistance for USDA audits.

DEA Related Services:

  • Assisting with Facility Registration, security requirements, recordkeeping, inventory management, reporting, compliance audits, labeling and packaging, disposal, and import/export requirements.

  • Ensuring compliance with DEA regulations to help prevent the misuse and diversion of controlled substances.

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