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Periodic review of standards and regulations, gap analysis
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Periodic data and trend analysis
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Internal audits
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Complaint management, incident investigation and reporting, recall management, periodic reports
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CAPA management
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PMS, PMCF
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Regulatory compliance and QMS training
Compliance
Constantly meeting changing compliance requirements could be challenging.
KeyMedic offers guidance through regulatory and quality compliance requirement, including:
What We Do
KeyMedic provides consulting services to the medical device industry, specializing in regulatory, quality and compliance solutions.
To help you even more we collaborate with Parente Studio, a Design and Development company that can help bring your company and product to the highest professional level.
Strategic Regulatory Consulting
Strategic regulatory consulting, development of regulatory plan, clinical investigations, regulatory submissions and more.
Quality Management Systems
Establishment and implementation of Quality Management Systems, inspection preparation & readiness assessment and more.
Quality & Regulatory Complience
Design control, V&V, risk management, quality audits, post market surveillance, recall management and more.
Branding, Design & Development
Branding, Logo, Business Cards, Product & Packaging Design, Website, Conference Booths, Ads, Brochures, Labeling, Patient Leaflets, User Manuals and more.