Quality is Our Standard
BioMed Diagnostics is dedicated to designing and manufacturing devices that meet or exceed customer expectations.
BioMed Diagnostics is dedicated to integrating the highest quality standards into every facet of our company. We are committed to meeting all applicable regulatory requirements and to continually improve the effectiveness of our Quality Management System by periodic reviews carried out by management. All production is compliant with U.S. 21 CFR 820, Good Manufacturing Practices.
BioMed Diagnostics is committed to high quality control standards in operations and in distribution. Management is further dedicated to ensuring a safe workplace and to supporting the professional growth of employees through training and support of continuing education.
We hold the following values, reflecting our high standards and commitment to quality:
- Integrity
- Communication
- Constant improvement
- Sound decision-making
- Acknowledgment and appreciation
ISO and CE Markings
BioMed Diagnostics' Quality Management System is ISO 13485:2003 certified by BSI Global. ISO 13485 medical device manufacturing certification ensures a customer focus and the delivery of reliable, safe and effective medical devices, IVDs and industrial and research products. Click here to download a copy of our Certificate of Registration.
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BioMed Diagnostics medical products also bear the European CE Mark; they are in compliance with and meet all of the appropriate provisions of the 98/79/EC Directive, including those related to safety. These products can be marketed anywhere in the EU without further control.
Below is the symbol key for CE Marking:
