Pre-Market application support, Gap Analysis – extra quality resources towards QMS certification + MDSAP with mock audits, classification selection, CE/UKCA marking certification support, technical documentation/dossier assistance & post market surveillance advice:
By focusing on Process, Product, and People, strategic Medical Device Companies employing selective Eclevar quality professionals can deliver strategic business excellence and customer-centric processes that lead to successfully marketing a medical device (SaMD).
A focus on Process means that the process pathway addresses all stages of the PMA medical device life cycle, from research and development to production and distribution, and with Eclevar contribution have been optimised for qualitycompliance against mandatory ISO’s. This ensures that the materialisation of a device (SaMD) is supported by detailed compliance processes are expected to offer objective auditable evidence that is deemed to meet the necessary regulatory MDR standards and provides customers with confidence that quality certification within your Company exists.
Product pathway shall ensure that the device (SaMD) is designed and manufactured to meet strict PMA regulatory standards that Eclevar can support. This includes ensuring that the device (SaMD) is safe, effective, reliable and fully tested with objective evidence, captured within DMF-DMR/DHF-DHR and technical dossiers.
Finally, People play a crucial role in producing processes and products. This includes ensuring that the right competent people are in place, with the necessary skills and expertise, to manage the process and product quality. This also includes ensuring that all employees understand the importance of compliance and are trained in the QMS Procedures for achieving the activities, responsibilities and authorities required of them. Eclevar can provide competent resource that tops up your staffing levels.
Eclevar can assist you in understanding the impact on your business by complying with:
This mandatory standard is specifically designed for the medical device industry and provides a comprehensive qualitymanagement system that covers all aspects of the medical device lifecycle, from product design and development to production and post-market surveillance.
This mandatory standard provides a systematic approach to risk management that helps medical device manufacturers identify and evaluate the risks associated with their products and implement mitigating measures to reduce the impact or control those risks.
This mandatory standard provides a systematic and comprehensive approach to software development for medical devices (SaMD), ensuring that software is developed in a safe and reliable manner.
This standard provides guidelines for the design of medical devices with a focus on usability, ensuring that medical devices are easy to use and reduce the risk of user errors.
Use: This standard provides guidelines for the design, conduct, and reporting of clinical trials for medical devices, ensuring that trials are conducted in a safe and ethical manner and that the results are reliable and credible.
By focusing on Process, Product, and People, our expert team can support manufacturers in producing medical devices that meet mandatory ISO standards.