When multiple employees of a Fortune 100 medical equipment manufacturing company reached out to us for support with workflow functions and permissions, we knew there was a better way. Rather than fixing the issues that would inevitably keep occurring with their...
When a global leader in infusion therapy, pain management technology, and support was developing more complex systems, they required an effective design control solution to support those efforts. SPK stepped in to help the medical company implement Windchill...
Innovation is essential for staying ahead of competition in all industries, but especially in healthcare. Staying up to date with new technologies and compliance needs can improve outcomes for patients. The best way to ensure compliance is by utilizing the proper...
The medical device industry is one of the most regulated industries due to the importance of the products they manufacture. Efficiently producing high-quality products that comply with regulatory standards is the key to successful medical device manufacturing....
Cybersecurity is important in every industry but is especially vital in healthcare. Safety, compliance, and data protection become more important than ever. With cyber attacks on the rise, protecting sensitive patient data has become a main priority. Let’s explore...
This article reviews what an FDA 483 Observation looks like, some of the more common issues flagged in medical device companies, and how to respond.
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends. One of the problem areas most often cited in company audits continue to be the CAPA system/program. This month we will take a look at some of the latest FDA...
Organizations in the medical, pharmaceutical, and life science industries are constantly adapting to their field’s rapidly changing technology and regulations. This continuous adjustment can become exhausting. Between this burnout and being unsure if your technology...
Engineers typically have a few distinct materials to work with when designing and manufacturing parts. Composite design allows them to combine two or more varying materials to create a new one. This new material is often sustainable and used to design structures. This...
Ensuring medical device quality is critical. So, you’ll need to understand and meet ISO requirements to appeal to potential buyers and streamline management. In this blog, we discuss ISO 9001 as it relates to medical device manufacturing, what your business can do to...
Ensuring regulatory compliance and fostering trust in products are paramount for medical device manufacturers. The FDA, European Competent Authority, and Health Canada closely oversee design, development, and manufacturing for patient safety and efficacy....
