In this challenging business landscape, companies must embrace innovation while managing global product development, outsourcing design and manufacturing, using the latest technologies – and continuing to meet strict regulatory requirements.
At Syncroness, we specialize in helping leading medical technology providers embrace innovation while meeting strict regulatory requirements. In particular, we can prototype, develop, and manage your entire project, including fabrication and validation of clinical units, tailoring our skill sets to your specific demands. Our medical device-related technology expertise includes the following:
We can help you with all phases of product development – from initial feasibility studies and voice of the customer research to analysis, design, and rapid concept development. Our team brings extensive medical industry knowledge and experience to the table, which proves extremely beneficial during the 510(k) and PMA submittal process and through the verification and validation phases.
Additionally, we design and manufacture production work cell systems, so you can ensure your manufacturing processes are efficient and effective. And when you need to focus on bringing new products to market, we can step in to help you maximize the life and revenue of existing products through our sustaining engineering, value analysis and value engineering, and product enhancement services.
We design successful medical devices by avoiding common quality and regulatory pitfalls – as we push the envelope, we also ensure compliance with ever-changing requirements imposed by medical device enforcement agencies. Syncroness is ISO 13485 certified, which means we meet regulatory requirements for medical device systems and maintain a medical device risk management system. And to ensure our designs use the highest-quality and technical standards, we meet FDA quality system regulations (21 CFR Part 820) and IEC 60601 safety and effectiveness standards.
Together, we can assess market needs, build risk mitigation strategies, and engineer processes for improved performance, enabling you to do what you do best – provide the best possible service to your customers and develop breakthrough medical devices to stay on the cutting edge of the industry.