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Medical Instruments Manufacturing Consultancy

Detail about our service

Cedars International Medical Instruments

Providing healthcare professionals and patients with quality medical devices hinges on factoring regulatory standards into the manufacturing process. Cedars International provides the compliance insights necessary for ensuring safety and quality are maintained.

Cedars International Building Compliance Through All Stages of Manufacturing

  • Comprehensive validation, covering devices, processes, and software
  • EU Medical Device Regulation (MDR) Compliance
  • In Vitro Diagnostic Regulation (IVDR) Compliance
  • Handling new product regulatory applications
  • Development and creation of Clinical Evaluations Reporting (CER)
  • Corrective Action/Preventive Action (CAPA) procedures, GxP validation, and the necessary documentation
  • Restriction of Hazardous Substances (ROHS) concerns, such as tin-based solder issues
  • Testing requirements, Complaints and recalls
  • Meeting manufacturing compliance in foreign markets

From design to development to testing, Cedars International directs quality, compliance, and regulatory efforts at each phase of the manufacturing process. Our experience allows us to assist with devising proactive strategies that include compliance awareness throughout a project, rather than as a bolted-on addition.

Cedars International consulting expertise is built upon our in-depth knowledge of the medical device manufacturing industry and our expertise in devising effective compliance strategies. By partnering with us, manufacturing enterprises are directed on how to implement effective solutions that drive business objectives and establish trust with clients.

Make an appointment

We will send you a confirmation within 24 hours. Urgency? Call +98 921 545 7608

We are experts in providing bespoke turnkey solutions and, through our multidisciplinary team and network of connections, can provide knowledge in areas such as architecture, engineering, medical equipment, people and goods flows, international guidelines and best practice, IT infrastructure, support services and project management.

Department Address

Box 3233 1810 Kings Way King Street, 5th Avenue, New York

+1-2345-3455-33
contact@mediztheme.co

Department Hours

Monday - Friday08:00 - 20:00
Saturday09:00 - 14:00
SundayClose

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