Professional Surgical Instruments Co. Inc. (PSI) is a medical device company centrally based in New Jersey, USA. Our company has been supplying medical and surgical instruments for over three generations. We strictly adhere to the quality standards of regulating bodies and we currently hold the FDA, CE, SA8000, ISO 13485: 2016, and ISO 9001:2015 certifications. This article will elaborate on what these regulating certifications mean and the quality standards we fulfill to bring you the best medical devices in the market.
FDA
FDA, or the Food and Drug Administration, is a medical device regulation system. To become FDA certified, a company must undergo a Premarket review, clearance, and approval.
The FDA divides medical devices into three categories: namely Class I, Class II, and Class III devices.
Class I devices are considered low risk and may not have to undergo the regulatory process. On the other hand, class II devices are required to present with a premarket notification of 510k to be considered equivalent to a previously approved device. Class III devices are used for life support or are required to be implanted into the body; hence they are considered high risk and require extensive analysis. On the other hand, a medical device that the FDA approves is considered safe for patient use. (1)
The bulk of PSI medical devices are Class I and our facility can be found on FDA’s “Greenlist”.
CE
While FDA is mostly regulatory in the United States, CE marking is required for medical devices used in the European Union. Having this marking is indicative of the device complying with the EU regulations, which are similar to and overlap with FDA’s regulations. Once the company can attain this marking, it can promote and commercialize its devices among all the European Union member states. (2)
All PSI instruments are CE certified and come with CE markings unless your requirement indicate otherwise.
SA8000
SA8000 is a system that is required to implement and ensure an effective management structure within an organization. The SA8000 ensures the management of a company's policies, procedures, and records. It is required for the special performance of the team and the assessment of risks. This certification also ensures that the company has effective preventative and corrective measures and ensures that there is enough stakeholder engagement and external involvement as well.
At PSI, not only is our manufacturing facility SA8000 certified, but we also take the time to know our materials, know our workers, and know our customers, so we can bring you the absolute best products you need, without compromising fairness or quality at any step along the way.
ISO 13485: 2016
Having an ISO 13485:2016 shows that the company has taken ample measures to ensure its quality control and ability to provide medical devices meets customer demand and needs. This also signifies that the medical device company consistently meets the applicable regulatory requirements and provides safe and high-quality devices. The ISO 13485:2016 can be attained during any phase of the organization's lifecycle, whether design, development, production, or storage. It may also involve the distribution, installation, and servicing stages. (3)
Through years of rigorous effort and uncompromising determination, we at PSI have perfected excellence in instruments to become a company relied on by some of the biggest names in the medical industry.
ISO 9001:2015
The ISO 9000:2015 certification shows that the company is compliant with the core of all international quality standards. This ensures that the medical device company is not only able to meet the specific regulatory requirements but also the customer’s needs.
The Bottom Line
Medical and surgical devices in the United States are considered high risk, and their safety and quality are considered a high priority amongst health care systems. Therefore, every medical device introduced must undergo a strict premarket evaluation and approval by regulatory authorities. Among the most highly respected medical device regulations are the FDA, CE, SA8000, ISO 13485: 2016, and ISO 9001:2015.
References
- National Academy of Engineering (US); Institute of Medicine (US); Ekelman KB, editor. New Medical Devices: Invention, Development, and Use. Washington (DC): National Academies Press (US); 1988. Available from: https://www.ncbi.nlm.nih.gov/books/NBK218290/ doi: 10.17226/1099
- French-Mowat, E., & Burnett, J. (2012). How are medical devices regulated in the European Union?. Journal of the Royal Society of Medicine, 105 Suppl 1(Suppl 1), S22–S28. https://doi.org/10.1258/jrsm.2012.120036