Quality Management Systems Consulting
From small startups to large international companies, Winovia provides consulting that focuses beyond compliance to usable, effective, efficient and sustainable quality management systems (QMS) for medical device manufacturers, contract manufacturers and suppliers. Winovia partners with companies improve and transform their quality management systems and processes.
Remediation
QMS Remediation
Winovia can provide you with a comprehensive quality management system improvement and remediation strategy. We will work with you to assess your quality management system, identify gaps, establish a comprehensive remediation strategy, and even lead and manage the remediation in a cost-effective and timely manner. Winovia has the experience to guide you in:
- Addressing FDA Form 483s, Warning Letters and Consent Decrees
- Addressing Notified Body regulatory non-compliances
- Helping you comply with the ever-changing requirements from regulations and standards
Management
Interim Quality Director
Dr. Sastri has acted as the interim Quality Director for numerous medical device companies during their remediation initiatives. He works with management to develop organizational competence and ensure continuity, compliance and long-term sustainability, while also assisting in identifying and vetting potential candidates.
Quality Systems
Quality Systems Regulations (QSR) and Current Good Manufacturing Practice (cGMP) expertise
Winovia can guide you towards a compliant quality system, whether you need to meet requirements of a single regulatory body or harmonize your quality system with multiple regulatory bodies around the world. Regulation expertise includes FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, EU IVDR and MDSAP.
Additional Consulting Expertise Includes:
Risk Management, Risk Analysis, FMEA
Design Controls
Process Validation
Test Method Validation
Supplier Quality Management
Management Controls
Consulting Contact Form
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