QuaRDA Consulting
Quality Regulatory Design Assurance
Services
Consulting services can meet a wide variety of needs from conducting audits to creation of a Quality Management System. Located in central Connecticut, Liz is a quick trip to Boston, Providence, New York and more.
Supplier Management
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Establishment of Approved Vendor List procedure
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Manage Supplier Quality Agreements
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Perform supplier audits
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Create procedures to manage third party manufacturing
Audit Services
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Serve as host to third party auditors (Notified Body, FDA, other Government Agencies, customers, etc.)
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Act as an independent internal auditor to meet annual requirements or to prepare for third party audits
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Conduct supplier audits in US with opportunity for OUS
Design Assurance
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Establish initial procedures to document product design
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Develop procedures for stages of development (concept, feasibility, verification and validation, production and design transfer, post-market)
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Software development life cycle within medical device regulations
Quality Management
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Creation and improvement of procedures for design, development, software, and production
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Conducting Lot Release processes and other Quality Control and Inspection activities
Regulatory
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Plan and manage FDA regulatory submissions
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Establish accounts with FDA for establishment registration, Medical Device Reporting, Electronic Submissions
Other
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If you don't see a service to meet your needs, reach out via the contact page