Dynamic EMS achieves ISO 13485 certification targeting the MedTech device market
Author : John Dignan, Managing Director, Dynamic EMS
04 December 2017
BSI-Assurance-Mark-ISO
UK electronics manufacturing service provider, Dynamic EMS has secured high-level authorisation from the BSI confirming that its facility complies with the requirements of ISO 13485.
The company is confident that this achievement will enable it to accelerate its growth into the medical device market sector.
Headquartered in Dalgety Bay, Scotland, the EMS provider has secured ISO 13485 certification, which demonstrates its commitment to efficient quality management systems (QMS), meeting international regulatory, safety and quality concerns specific to the medical device industry.
Dynamic EMS, which employs approximately 90 people, continuously monitors global industry trends, and believes that the MedTech device market holds significant potential for manufacturing and supply chain solutions to be sourced from their base, and to act as a gateway for European and North American original equipment makers (OEMs).
This step toward IS0 13485 accreditation further highlights the strategic initiatives that Dynamic EMS is undertaking to ensure the company has the right mix of traditional and non-traditional electronic manufacturing customers, supporting their needs through the entire production lifecycle from design, to development, to distribution and beyond.
The quality certifications enable the company to tailor-make customised solutions to customers in the MedTech and pharma industry, including the medical device sector, while also enhancing Dynamic EMS’s ability to support customers in regulatory audits from bodies such as the FDA. This is why the company refers to itself as its customers' product solutions architect.
John Dignan, Managing Director, stated that their current experience with medical companies has led the organic decision for them to deepen their service level, capabilities and competencies. In this statement, he lets us know why he believes Dynamic EMS will be the natural choice for medical device companies.
“Dynamic EMS recently celebrated its 60-year anniversary. During this time, we have built up a wealth of knowledge and expertise, which has contributed to our ISO certification diversity. Quality is a key value embedded in our culture. All of the services offered by Dynamic EMS are underpinned by our QMS, as we understand that working in high-reliability market segments means quality and reliability are paramount. Our in-house QMS system ensures our customers have complete traceability throughout the product build and conform to required industry certifications.”
Dignan further stated that the company has already won several contracts in the area and are building on their experience with pharma companies.
“Our team has been working within the MedTech device market for a number of years, and have, through our closely collaborative customer relationship, developed real intelligence, insights and expertise in this area.”
Dynamic EMS has a solid understanding of the requirements needed to meet this evolving market sector. The manufacturing facility is currently certified to ISO 9001 and, as of November 2017, is now ISO 13485 compliant.
It is clear that Dynamic EMS is ideally positioned as a leading supply chain solutions provider for the MedTech and pharma sectors in the UK, across Europe and the Americas.
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