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Quality

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Fully compliant Quality Management Systems
Our Quality Management Systems are fully compliant with medical device design and manufacturing requirements in the US and around the world. The systems are flexible enough to allow our experienced quality engineers to comply with our customers’ requirements or leverage our own internal requirements.
Comprehensive QMS

We have full quality engineering capabilities to support you throughout your project. Our comprehensive Quality Management Systems encompass:

Regulatory support

Our experienced regulatory staff can act as an extension of your regulatory team, supporting you with services including:

  • Regulatory strategy
  • Pre-submissions
  • 510(k) preparation
  • CE Mark tech file preparation
Quality assurance

We use a variety of quality tools and control systems to ensure we meet your quality needs and finished product specifications. From incoming raw material inspection to finished product release and validation testing, our quality team and enterprise resource planning (ERP) system control all aspects of the production process.

Our process of quality assurance starts with the design of the product and production system. Our engineers collaborate with you and recommend materials, tools, and design modifications to improve product manufacturability. Our suppliers and partners are all carefully qualified and managed to ensure raw materials meet the required standards. We also use corrective and preventive action (CAPA), complaint handling, and process controls to ensure that we produce high-quality, conforming components.

We understand that a carefully constructed process should be methodically validated, audited, and improved—which is why we use advanced technologies and methodologies throughout each production run to ensure that components and devices meet the required standards.

  • Problem-solving & operational quality
  • Six Sigma problem-solving tools (DMAIC, 8D)
  • Work flow diagrams/Process mapping
  • 5 Whys
  • Ishikawa diagrams
  • Cause and effect matrix
  • Is/Is not analysis
  • Pareto analysis
  • Control plans/charts
  • Standard work documentation
  • Development & validation
  • Design development planning
  • Risk analysis and risk assessment (AFMEA, DFMEA, PFMEA)
  • First article layouts and approvals
  • Process capability studies (Cpk, Ppk, tolerance intervals)
  • IQ, OQ & PQ validations
  • Lab testing for analysis and compliance
Committed to regulatory compliance
As an ISO 13485 certified and FDA-registered partner, we recognize the importance of regulatory compliance in medical device manufacturing. We share your commitment to and responsibility for compliance with regulatory requirements wherever your devices are marketed. Our systems are built with regulatory compliance in mind — from design, development, and manufacturing to purchasing and record archiving. We strive to maintain a constant state of readiness for regulatory inspection by effectively executing our Quality Management Systems in all aspects of our business.
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