Getting ISO 13485 Certified in Dayton, Ohio (OH)
ISO 13485 is the International Quality Management Systems (QMS) standard. It provides a set of principles for your company to ensure a common-sense approach to managing your business activities to consistently achieve customer satisfaction while standardizing your processes and continuously improving business process efficiency.
By assisting ISO 13485 certification for companies in both existing and new markets, we give them the ability to expand. There is also a general increase in the efficiency of the service/product delivered to the consumer. Having your certification would have a competitive edge over other rivals and can improve customer acquisition capabilities.
Get ISO 13485 certified in only 5 steps!
Contact us and share the requirement
We’ll do your organization’s gap analysis about the ISO 13485 and send you a quotation.
Documentation and training
If you are happy with our quote, our staff will provide you with the requisite training and complete the documentation research needed for ISO 13485 certification.
Implementation and a review
We will then conduct a pre-evaluation audit to ensure that your organization meets the certification requirements you would like.
Final audit carried out by a certification body
During the final compliance process, we will be offering assistance to ensure that the company effectively completes compliance.
We are an organization conscious of quality and believe in total customer satisfaction. We know you will be 100 percent happy with our service and look forward to you receiving your certification.
How ISO 13485 is universally recognized?
ISO 13485 has a strong focus on harmonizing a quality management system within regulatory requirements for medical devices. It isn’t surprising that there are many jurisdictions recognizing or even requiring manufacturers of Medical Devices to obtain an ISO 13485 certificate for access to their market. As part of their own criteria, a range of regulatory bodies has implemented an ISO 13485 classification framework to authorize selling Medical Devices in their territories. The MDSAP has gone one step further: it is based on the principles of ISO 13485 and incorporates its principles as part and parcel of the specific audit criteria.
Why choose ISO 13485
With ISO 13485 being ISO 9001 based, it is designed for compliance with the regulations. Therefore it will be more prescriptive in its nature and also requires a much more thoroughly documented system of quality management.
ISO 13485 has been written to assist manufacturers of medical devices in the design of quality control systems which create and sustain the efficiency of all their processes. Yet, it ensures the consistent design, including development, manufacture, installation, as well as delivery of safe medical devices for their main intended purpose.
Risk assessment and risk-based decision-making are stressed with systems outside of the context of drug realization. The focus is on risks associated with medical device safety and performance, and compliance with regulatory requirements. Furthermore, the standard allows businesses to be very careful when it comes to procurement processes by enforcing guidelines, such as written agreements, for evaluating their vendors – again based on risk.
ISO 13485 is also reflective of increased regulatory requirements for organizations across the supply chain of medical devices.