Balancing speed and compliance in medical device engineering can be challenging. Engineers face tight deadlines and detailed requirements to bring life-saving products to market. Your CAD workflows should aid in the path to compliance and accelerate FDA approval. As...
Digital disruptions such as cyberattacks or system failures are one of the largest threats to the financial sector. Recognizing the increasing reliance on digital infrastructure, the European Union introduced the Digital Operational Resilience Act (DORA). This act...
Market traders understand the importance of timing in the trading industry. Each day missed (or hour missed) is considered lost revenue. When a proprietary trading firm began to miss trading days due to issues with its software, leaders of the firm contacted SPK to...
Effectively managing software licenses can be challenging, but it is critical in ensuring your organization works cost-efficiently. These challenges only increase when vendors make unexpected changes. This was precisely the case when Klocwork, a leading static code...
Compliance with regulatory standards is the number one priority for every medical manufacturer. Ensuring pipelines are secure and compliant doesn’t just ensure safety, but it results in better quality products. When a startup medical manufacturing company contacted...
The release of the FDA final rule on Unique Device Identification (UDI) is expected this summer. Here are five things you need to know: 1. What is the UDI Rule? In July 2012, the FDA proposed a rule requiring medical device manufacturers to label their products with...
Medical Device manufacturers regulated by the FDA are subject to cGMP (Current Good Manufacturing Practice) regulations and may be inspected by the FDA to ensure compliance. If the FDA inspector(s) observes conditions that in their judgment may constitute violations,...
You will be taken to another page to registerBy submitting this form, I acknowledge receipt of SPK and Associates' Privacy Policy.As software-driven complexity grows across industries like automotive and medical devices, engineering teams are facing unprecedented...
Implementing a Quality Management System (QMS) that ensures compliance with ISO 9001 is a strategic decision for organizations. Implementing this system enhances customer satisfaction, improves efficiency, and drives continuous improvement. However, achieving ISO 9001...
Executive Summary That’s the year public and private cloud-based solutions are set to surpass traditional data centers in terms of overall spending. In 2017, nearly two thirds of spending went toward private cloud solutions. Cloud usage exploded in 2017, to the tune...
Executive Summary In 2020, public and private cloud-based solutions like Amazon Web Services surpassed traditional data centers in terms of overall spending. In 2017, nearly two thirds of spending went toward private cloud solutions. Cloud usage exploded in 2017, to...
Developing new and innovative products is essential for companies to survive and thrive -- however safety can never take a backseat to innovation. That is why many companies, like those in the Medical Devices, Aeronautics and Automotive industries, have strict...