A collaborative study with Harvard Medical School
We at Axio benchmark ourselves to global standards and follow appropriate regulatory guidelines in respective countries of operation.
Setting the Benchmark for Advanced Wound Care Solutions
Axio is committed to providing novel healthcare solutions from India to the world, high in quality and complying with appropriate standards. Our highly skilled & professional teams engaged in Research & Development, Quality Assurance, Quality Control, and Regulatory Affairs ensure that Axio’s products and services are always up to the mark.
Quality Assurance
At Axio, our competent QA team ensures that Axio’s products meet or exceed all relevant requirements and standards for the design, manufacture and distribution of advanced wound care products.
We ensure high quality and reliability from raw material procurement to delivery.
Quality Control
Our proficient QC team ensures all the validated processes and quality checkpoints are followed strictly to ensure that the final product is satisfying the customer’s requirements and set acceptance criteria before the product is released for distribution to the end-user.
Regulatory Affairs
Axio’s proactive RA team ensures that we are in substantial compliance with an extensive set of requirements set forth by FDA, EU, ISO, and other regulatory bodies. RA team is majorly responsible for obtaining market clearance for our products by regulatory submissions according to the set regulations.
Axio products are approved in 50+ countries
Our Key Regulatory Approvals/Certifications
CE Certificate - Axiostat
Axiostat CE Certificate, which is issued under MDD 93/42/EEC, has received an extension until 31st December 2027 under Regulation (EU) 2023/607.
Axiostat
USFDA 510k Cleared
Axiostat Patch: 510k K202830
Axiostat Chitosan Haemostatic Dressing: 510k K172324
Scan QR codes to verify certificates using blockchain. To know more, visit DNV Blockchain verification
Other Certifications
- GMP Certification
- CDSCO approvals for Axiostat & Maxiocel
Risk-Based Approach
We, at Axio, conduct a risk-based analysis of design, processes, and other relevant functions followed at the facility to determine and implement appropriate risk mitigation controls throughout the life cycle of our products.
Even after placing the device on the market during the use by healthcare professionals, Axio has implemented an extensive feedback process for seeking any window of improvisation.
Inspection and Monitoring
Axio believes in self-assessment and improvement, for which we periodically audit compliance with our policies and procedures. We ensure that continuous monitoring of all the QMS aspects is reviewed, audited, and fixed on time.
QA & RA at Axio operates in close collaboration for successful conformance of the requirements as an outcome improvement activity and those set forth by different regulatory authorities.
Not a Drug Manufacturer
Axio is in accordance with the provisions of the medical device legislation to the best of its knowledge as it is a medical device producer and not a drug manufacturer.
*Approvals provided here are specific to certain geographies. Kindly check indications that are applicable to your jurisdiction prior to use.