Quality & Compliance
Our commitment to excellence through rigorous standards and processes.
Industry Recognition
Our Certifications
Bloflex Surgicle Industries maintains the highest quality standards through adherence to international certification requirements.
ISO 9001:2015
Quality Management System certification ensuring consistent, high-quality products and services.
ISO 13485:2016
Medical Device Quality Management System certification specific to the medical device industry.
MD Compliant
Good Manufacturing Practice compliance ensuring products are consistently produced according to quality standards.
Process Excellence
Quality Assurance Process
A comprehensive system covers everything from raw material selection to final product inspection. Here’s our rigorous multi-step process:
All incoming materials are thoroughly tested for compliance with specifications before use.
Multiple checkpoints during manufacturing verify dimensions, functionality, and specifications.
Sterilization processes are validated and monitored to ensure effectiveness and safety.
Statistical sampling and testing before release to ensure all quality requirements are met.
Safety & Integrity
Sterilization & Packaging Process
Our sterilization and packaging processes ensure product safety and maintain sterility until the point of use.
Steam Sterilization Methods
We employ industry-standard sterilization methods validated to ensure the highest levels of product safety.
- Ethylene Oxide (EtO) Sterilization
- Gamma Radiation Sterilization
- Steam Sterilization for applicable products
Packaging Materials
We use only high-quality, medical-grade packaging materials designed to maintain product sterility and integrity.
- Medical-grade paper-film ribbon packs
- Auto sealing pouch packing system
Quality Verification
Our packaging undergoes rigorous testing to ensure it maintains sterility throughout the product lifecycle.
- Seal integrity testing
- Accelerated aging studies
- Sterilization indicator verification
- Batch sterility testing
Our Promise
Quality Commitment
At Bloflex Surgicle Industries, quality isn't just a department—it's a company-wide commitment embedded in our culture. Every employee, from management to production staff, is responsible for maintaining our high standards.
Continuous Improvement
We regularly review our processes and systems to identify opportunities for improvement, ensuring we stay at the forefront of medical device manufacturing.
Employee Training
Our staff undergoes regular training on quality procedures, regulatory requirements, and good manufacturing practices to maintain the highest standards.
Customer Feedback
We actively seek feedback from healthcare professionals to continually enhance our products and better meet the needs of medical practitioners.