11 Dec 2017 ISO 13485 Accreditation
Dynamic EMS Targets the Medical Device Market
UK Leading Electronics Manufacturing Service Provider Dynamic EMS has secured high-level authorisation from the BSI confirming that the facility complies with the requirements of ISO 13485.
The company is confident that this achievement will enable them to grow into the medical device market sector.
Headquartered in Dalgety Bay, Scotland, the EMS provider has secured ISO 13485 certification, which demonstrates the facility’s commitment to efficient Quality Management Systems (QMS), which meets international regulatory, safety, and quality concerns, specific to the medical device industry.
Dynamic EMS, which employs approximately 90 people, continuously monitors the global industry trends, and believes that the medical device market holds a 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 taking part in to ensure the company has the right business 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 specific customised solutions to customers in the med-tech and pharma industry, such as 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 their customer’s 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 built 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.”
John 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 medical 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 med-tech and pharma sectors in the UK, across Europe and the Americas.