ISO 13485 Certified | CE Marked under MDR | DNV Notified Body | International Supply
Aditya Dispomed Products Pvt. Ltd. is a manufacturer of sterile disposable medical devices supplying international markets under structured quality and regulatory systems.
Our operations are governed by certified management systems that support product conformity, regulatory compliance, traceability, risk management, and continual improvement across the product lifecycle.
Quality and regulatory compliance are integrated into every stage of our operations — from supplier qualification and controlled manufacturing to final inspection and post-market monitoring.
Our Quality Management System is structured in accordance with international regulatory expectations and is independently assessed by accredited third-party certification bodies.
Our Quality Policy defines our commitment to meeting applicable statutory and regulatory requirements, ensuring product safety and performance, maintaining an effective Quality Management System, and driving continual improvement.
Our corporate Quality Objectives are aligned with ISO 13485 requirements and are reviewed during Management Review to ensure continued relevance and effectiveness.
Performance against defined targets is monitored at planned intervals.
Aditya Dispomed Products Pvt. Ltd. is a CE-marked medical device manufacturer. Conformity assessment activities are conducted in accordance with applicable European regulatory requirements.
Our Quality Management System is certified by DNV (Det Norske Veritas), an EU-designated Notified Body authorised for medical device conformity assessment.
Our CE certification is extended until 2028 under the transitional provisions of Regulation (EU) 2023/607, amending Regulation (EU) 2017/745 (MDR).
CE marking applies to products within the certified scope.
In alignment with Regulation (EU) 2017/745 (MDR), Aditya Dispomed Products Pvt. Ltd. is progressing regulatory compliance activities in preparation for full MDR implementation requirements.
We maintain structured regulatory processes supporting:
EUDAMED-related obligations are monitored in accordance with applicable European Commission timelines and module activation status. Registration details and regulatory documentation are made available to authorised partners and competent authorities as required.
Our regulatory framework is structured to support continued market access under MDR transitional provisions and future MDR conformity assessment pathways.
We maintain an ISO 13485:2016 certified Quality Management System covering the manufacture and supply of sterile disposable surgical instruments.
Our operations are supported by an ISO 14001:2015 certified Environmental Management System, reflecting our commitment to responsible manufacturing and environmental stewardship.
We operate an ISO 45001:2018 certified Occupational Health & Safety Management System to provide a safe and structured working environment.
European Authorised Representative (EU REP)
UK Responsible Person (UKRP)
Swiss Authorised Representative (CH-REP)
Certification documents are available above for general reference.
Additional regulatory documentation, audit responses, scope clarifications, and compliance information may be provided as part of distributor qualification, tender submissions, and procurement due diligence processes.
Contact our Regulatory or Sales Team for documentation requests.