Healthcare

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Medical Device Design and Development

Designing medical devices with a focus on usability and safety, complying with FDA regulations and ISO 13485 for quality management.

 

Prototyping and Compliance Testing

​Developing and testing prototypes to meet healthcare regulations and ISO 14971 for risk management.

 

Medical-Grade Component Manufacturing

Utilizing biocompatible and sterilizable materials in manufacturing, complying with ISO 10993 for biocompatibility and ensuring processes meet ISO 11135 and ISO 17665 for sterilization of healthcare products.

 

Digital Health Solutions

Creating user-friendly interfaces and digital health solutions that enhance patient engagement and comply with HIPAA for patient data protection.

 

Compliance and Regulatory Support

Providing guidance on compliance with healthcare industry standards like ISO 13485 and FDA regulations.​