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MedTech Outlook | Saturday, February 26, 2022
Quality assurance teams of EMS providers are highly skilled and knowledgeable about the regulatory landscape for manufacturing safe and effective medical equipment.
Fremont, CA: Original equipment manufacturers (OEMs) of medical devices are continuously under pressure to offer innovative items faster than their competitors while maintaining high quality. To stay on top of the competition, there is usually only a little window of time to finalize a design, advance it to the prototype and NPI stages, begin producing a device, and obtain the necessary regulatory clearances.
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Original equipment manufacturers (OEMs) of medical devices are continuously under pressure to offer innovative items faster than their competitors while maintaining high quality. To stay on top of the competition, there is usually only a little window of time to finalize a design, advance it to the prototype and NPI stages, begin producing a device, and obtain the necessary regulatory clearances.
OEMs must also adjust to changing regulatory criteria on a regular basis. For example, beginning in July, modifications to long-standing RoHS (Restriction of Hazardous Substances) medical exemptions will make it illegal to utilize lead in medical device designs. OEMs are scrambling to update product designs and restructure elements of their supply chains in order to ensure that forbidden materials are eliminated from the process, and that change declaration is completed by summer. OEMs must also certify products in accordance with EU REACH regulations, ensuring that dangerous compounds are not included in product designs. They're also reacting to new MDR (medical device regulations) and IVDR (in-vitro device requirements) legislation that requires OEMs to pursue supplier disclosures on potentially hazardous chemicals actively.
The COVID-19 pandemic has put medtech's supply chain flexibility to the test, on top of all of these industry problems. Many quality and regulatory operations, such as audits and document reviews, have to be transferred online to accommodate travel limits and physical distancing standards, in addition to creating various new processes to protect manufacturing workers.
Medical device OEMs were increasingly turning to electronic manufacturing service (EMS) providers even before many of these issues appeared to assist them in traversing the complexities of quality and compliance so they could focus on product innovation and intellectual property. Based on their work with hundreds of clients over the years, EMS providers have highly experienced quality teams who have complete knowledge of the regulatory landscape for manufacturing safe and effective medical devices.
Top EMS suppliers have a proven track record of quality and compliance, as well as the versatility to react to new rules and provide OEMs with the most compliant, safe, and effective products possible.
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