Navigating the complexities of ISO 14971:2019 can be challenging. But, with this eBook presented by SPK and Associates and PTC, you're taking the first step towards expertise in medical device compliance. What's In The ISO 14971:2019 eBook This comprehensive guide...
Medical Device Engineering
2022 Guide: Software as a Medical Device (SaMD)
What is software as a medical device? Software as a medical device, or SaMD is software that is intended for one or more medical purposes. This software performs those purposes without being part of a hardware medical device. SaMD devices also need to meet the...
Using Creo to Meet Stringent Regulatory Requirements in Medical Device Engineering
All medical device manufacturers understand that precision, safety, and regulatory compliance are vital in their industry. Without these precautions, individuals could be harmed. These strict requirements and extended life cycles often make the time between designing...
Achieving the Speed of Innovation and Maintaining Compliance in the Medical Device Industry
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...
Accelerating Medical Device Development with the Digital Thread
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....
Building Resilience in Healthcare IT Infrastructure through Cybersecurity Strategies
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...
Creo Composites Design & Manufacturing Capabilities
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...
ISO 9001: Quality Management in Medical Device Manufacturing
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...
Managing a Software Bill of Materials (SBOM)
The FDA's heightened cybersecurity standards, implemented in October 2023, have changed submission requirements for medical devices. In this blog post, we'll explore the key updates and detail key information about effective Bill of Materials (BOM) management,...
Design Controls Best Practices for Medical Device Companies
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....
Shifting from FDA 21 CFR Part 820 to ISO 13485
In this Vlog, Chris McHale, Co-founder, and CEO of SPK and Associates is joined by Carlos Almeida, Vice President of Engineering. Together, they’re discussing FDA compliance and the recent shifts impacting medical device companies. Topics for discussion include...
MasterControl’s Quality Management Software: Navigating Compliance with Confidence
Looking for a great out-of-the-box solution for a Quality Management Systems (QMS) that exceeds the compliance requirements for FDA? MasterControl could be a good option for you. It even includes the stringent guidelines outlined in 21 CFR Part 820. Let’s take a...