- Home
- Product
- About
- Contact
- Blog
Menu
BQ Plus Medical is committed to patient safety, product consistency, zero-defect quality culture and reliable regulatory documentation for disposable infusion therapy and enteral nutrition products.
QA & QC Team
Quality Assurance and Quality Control
BQ Plus Medical’s QA and QC teams support ISO 13485 quality management, incoming inspection, in-process control, final release, documentation control, validation support and continuous quality improvement.
As an assurance of patient safety, we establish our quality policy and devote ourselves to making a safer world by providing better quality, innovative, and effective products, parts, and sterilization services. That’s a process never ends-we continually reviewing our quality system and development against the regulatory requirement to ensure we are on the right path.
We share our patients’ concerns and understand how deeply they need proper care, the appropriate device when required, which is why we always strive to do better and more when it comes to this critical issue.
The quality policy below reflects our company’s focus on providing devices that patients can trust. We’ve worked hard to build and maintain this trust for many years.
ISO 13485:2016
EU MDR audit passed by TÜV Rheinland in December 2024; EU MDR / applicable CE documentation support
FDA registration, FDA 510(k) cleared products (K210381, K223645 and K242126), and FDA inspection passed with zero 483 observations on March 24-27, 2025
ANVISA-related documentation support where applicable
NMPA / China medical device documentation support
Traceability is a core requirement in BQ Plus Medical’s quality management system and is maintained across the device life cycle, from incoming materials and component production to assembly, EO sterilization, batch release, distribution and post-market activities.
Device History Records (DHR) support batch-level traceability and include key records such as raw material inspection, production and assembly records, in-process inspection, sterilization batch records, finished product inspection and release documentation. Relevant records can be provided to qualified customers upon request according to product, market and confidentiality requirements.
BQ Plus Medical supports post-market surveillance, complaint handling, UDI-related documentation and corrective / preventive action processes. The company also promotes Crosby Zero Defects quality culture, emphasizing conformance to requirements, prevention-based quality management and reduction of the price of nonconformance (PONC).
