Scapa Healthcare expands turn-key solutions with new Regulatory & Compliance Services

Today, Scapa Healthcare, a strategic outsource partner of skin friendly turn-key solutions for the healthcare industry, announces the launch of its Regulatory Services offering. Providing full-service regulatory and compliance support will afford customers a more comprehensive partnership for the design, development and manufacturing of skin contact solutions, particularly Class II & III medical devices.

Scapa Healthcare’s Regulatory Services are part of the Product-Life-Cycle Management process, adding an additional layer of support for customers needing assistance with regulatory planning from submission to clearance and post-market surveillance. Experienced regulatory experts will work with customers’ project management teams and regulatory departments to develop safe, effective, and compliant products.

The offering is designed to ensure compliance with regulatory requirements and assisting customers in eight key areas:
•              Pre and Post Audit Support
•              Provide Safety Regulatory Information
•              Design Plan Development
•              Document Preparation for Regulatory Submissions
•              Creation & Management of Design History Files
•              Navigation of Regulatory Pathways
•              Documenting & Executing Protocols / Testing for Validation
•              Post-Market Surveillance

“Our new Regulatory services is another example of the way Scapa Healthcare is committed to being a strategic outsource partner, assisting our customer in the development of their products, minimizing regulatory challenges and risk, and maintaining compliance,”  said Stephen Gilder, Vice President of Global Healthcare Quality. 

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