Are you a medical device start-up and in need of quality system procedures?
Are you an early-stage medical device company that may have some quality system procedures and need to fill in the gaps?
Are you an established medical device company that has a full suite of quality system procedures, but want to see how they compare to current best practice?
Efficient. Compliant. Affordable.
Covita Health Partners has developed a complete collection of quality system documentation that is available to purchase a la carte or as the full collection, all dependent on your needs. The collection is comprised of procedures, attachments and forms – over 150 individual documents in total to choose from.
The full collection would provide everything an organization would need to establish compliance to:
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21 CFR 820 Quality Management System
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21 CFR 820 Quality Management System Regulation (in effect February 2, 2026)
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ISO 13485:2016 Medical devices – Quality management systems
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ISO 14971:2019 Medical devices – Application of risk management to medical devices
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IEC 62304:2006 Software life cycle processes
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AAMI TIR57:2016/(R)2023 Principles for medical device security—Risk management
For those organizations in the EU or doing business in the EU, rest assured we’ve written the risk management and security procedures to take into account the General Data Protection Regulation (GDPR).
Procedures a la Carte
Choose only the procedures you need, when you need them.
If procedures a la carte fit your needs best, you can choose from procedures in the following general categories:
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Quality Management System
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Management Responsibility
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Resource Management
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Product Realization
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Measurement, Analysis and Improvement
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Management Review
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Audit Readiness
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Gap Analysis
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Quality Manual
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Cleanliness of Product
Reach out to learn more about our Procedures for Purchase.