Female surgeon secures her face mask in an operating room.

Global Quality & Regulatory Affairs

Vantive is committed to patient safety and delivering high-quality products.

Global quality policy

At Vantive, we are committed to providing safe and effective products and services to customers, earning trust from our patients with:

  • An uncompromising dedication to quality and compliance, inspiring and empowering all of our employees to help patients
  • A continuous assessment of our quality system to drive simplification and effectiveness and to improve the customer and patient experience
  • A relentless determination to comply with current regulatory requirements and monitor evolving regulatory trends, thus producing the highest quality innovative therapies
Ensuring Quality at Vantive: Global Quality & Regulatory Affairs

Frequently asked questions

What standards and regulations are applicable to Vantive?

The Vantive Quality Management System complies with key regulations and standards applicable to Vantive's businesses worldwide. A noninclusive list of regulations and standards includes U.S. Code of Federal Regulations Title 21 - Food and Drug, Canadian Medical Devices Regulations, European Commission Eudralex, European Union Regulations, Therapeutics Goods (Medical Devices) Regulations 2002, China GMP and its appendices for Drug and Medical Device (CFDA 2014 No. 64 Announcement), ISO Standards and Guidance, etc.

How many quality systems are followed?

Vantive has implemented a single global quality management system that ensures product safety and performance in accordance with applicable regulatory requirements. The quality system itself is defined through written requirements, processes and procedures; implemented through trained personnel; and documented through the generation of quality records that prove the written procedures were followed.

What type of certification programs does Vantive have for suppliers?

Vantive has a risk-based approach to third-party certifications and supplier qualification requirements based on the type of product or service provided, in compliance with the expectations of regulators.

How is Vantive ensuring that quality and safety commitments extend to the marketing teams?

Vantive has established processes and procedures to enable the effective and compliant promotion of Vantive's products, therapies and capabilities. Additionally, we partner with clinical education groups and provide external portals for customers to access relevant training information.