Sialkot, Pakistan (May 24th, 2024) – Acheron Instruments is pleased to announce a formal agreement with ECM and is currently working towards achieving MDR compliance for Class I and Class Ir reusable surgical and dental instruments.
In a significant step towards the European Union Medical Device Regulation (EUMDR), Acheron Instruments is currently in the process of implementing MDR-compliance and has applied to a Notified Body #1282 (EMC Italy) for a Conformity Assessment. We have appointed this Notified Body to provide us with the extension letter of MDR compliance for products (class 1 and class 1r) reusable surgical and dental instruments.
Acheron Instruments is required to reassess the products for compliance, an ongoing process that must be completed by December 2028. Given the extensive review of files and documentation involved, we are actively working on this comprehensive task. We estimate that it will take approximately 2 to 3 years to submit the proper documentation, which is why we have formally signed an agreement with the notified body for the MDR Certificate.
We have established a contract with EMC, a notified body specializing in medical device certification, to improve our quality management processes. This notified body will conduct audits and inspections of our products to ensure that they meet all requirements of the EUMDR criteria. They will oversee regular audits to determine if we are on track.
As a reputable company, Acheron Instruments' decision to obtain MDR Compliance demonstrates its commitment to upholding the highest standards of quality, safety, and regulatory compliance. This MDR compliance is essential for competitiveness in global markets and for ensuring the provision of quality-tested and safe medical instruments. The products will undergo assessment to ensure they meet the updated standards.
“We are excited to collaborate with ECM Italy to navigate the complexities of MDR compliance,” said Zohaib Tariq, COO at Acheron Instruments. He further stated, “This partnership will enable us to strengthen our quality management systems and ensure that our products consistently meet the highest international standards. By prioritizing regulatory compliance, we aim to build trust with our customers.”
This agreement is more than just a matter of regulatory compliance; it highlights Acheron Instruments' proactive approach to improving its product offerings and building customer trust. By collaborating with a globally recognized notified body, Acheron not only adheres to international standards but also establishes itself as a leader in innovation and quality within the medical device industry.
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