Risk Management and Compliance Consulting Services

 From design, to engineering, to testing, and beyond, your medical device risk management process is an integral part for every phase of the design. Whether you're seeking to design a new product or ameliorate and being one, your medical device risk management process must be rigorous; especially if you're trying to gain FDA & CE approval.

Still, this can lead to your system lacking certain mitigations if your medical device risk management process isn't done rightly. This not only affects your budget and increases time to deal, but if initiate late in the process you may be needed to redesign, redevelop, and check your device throwing your system off the rails. Since having these mitigations and good practices are core to the FDA & CE approval process as USFDARegulatory Consultants, you need an active medical device risk management process.

Using Experience and Knowledge to Produce A Balanced MedicalDevice Risk Management Process

Although it's important to have a active risk management process, if you spend too important time designing your process it can negatively affect your budget and timeline. It can be delicate to find the right balance. This is where Sterling’s expertise and experience since 1998 with over systems can serve as an asset. Sterling has the proper instruments and can ensure that your device meets the proper conditions, so the FDA & CE approval process goes easily with the help of USFDA Regulatory Consultants.

 Maximizing Effectiveness Through Experience

Our engineering methodologies are optimized to keep charges low and design times down. We know how to minimize the total duration of the design and maximize your return on investment. This is possible due to our rear engineering service which allows our customers to snappily produce prototypes and use previous work to induce all the necessary attestation needed for nonsupervisory blessing – all without compromising quality. We also employ nimble design operation by breaking down the design into incremental way, and completely reviewing each step. This allows us to efficiently make changes and take company feedback.

 ISO 14971

 ISO 14971 is the operation of risk management to medical device. It outlines the process you're going to follow for risk analysis. It entails going through risk analysis, a risk evaluation, risk mitigations, and a residual risk analysis and operation. This standard helps guide the process for medical device manufacturers to ensure that the product is safe. Sterling’s experts can give companies with support and documents demanded for the ISO 14971 operation.

Hazard Analysis

 As part of our mortal factors engineering process, we conduct a hazard analysis to identify implicit hazards or dangerous issues from the terrain and usability of the device. We also dissect residual threat of the device. Our thing is to ensure the device works duly and safely within its terrain.

Software FMEA For Medical Devices

 FMEA, which stands for Failure Modes and Goods Analysis, is a process which helps to identify issues before they be. The first step in this process is to imagine possible pitfalls with the software. The alternate phase involves deciding how mischievous the pitfalls are to the software. Grounded on this way, the third step is to develop safeguards or mitigations for those pitfalls.

IZiel has highly trained software engineers with multiple years of experience in software coding, software verification and software validation. The team consists of senior engineers who have worked in design and development of highly sophisticated implantable devices at industry leading companies, with direct expertise in software V&V. This team, with the support of IZiel’s regulatory and clinical experts, are decidedly equipped to handle complex software validation activities for medical device manufacturers. Integrating risk assessments into the validation lifecycle and documenting the basis for what was done also provides a level of assurance to management and regulatory authorities that the system was properly defined, designed, built, tested, operated, and maintained.

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