Featured Articles

  1. MasterControl Announces Annual Recurring Revenue Milestone 11/18/2021

    MasterControl, a global provider of software solutions for life sciences and other regulated industries, today announced it has reached $100 million in annual recurring revenue (ARR), led by their signature software solutions, Quality Excellence and Manufacturing Excellence, as well as the recent launch of MasterControl Insights.

  2. Vital Signs Of The Medical Device Industry 10/1/2021

    The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond. As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive.

  3. 5 Medical Device Best Practices For Managing Risk To Users, Patients, And The Environment 10/1/2021

    Medical device companies of all sizes are often concerned about speed-to-market, new device clearance overhead costs to maintain compliance, and lack of certainty about what is needed to maintain compliance, and fear of non-compliance consequences. We explain how to meet these compliance standards by following these best practices to bring new medical devices to market with success.

  4. Cybersecurity In Medical Device Development 10/1/2021

    Security now needs a seat at the medical device design table, accompanied by its own list of requirements. Here are resources to identify specific areas to focus cybersecurity efforts throughout the product’s life cycle.

  5. Compliance Tips For New Medical Device Products 9/30/2021

    How can you guarantee that your medical device will not only perform as designed, but also conform to the highest regulatory standards? By designing for compliance you can meet this goal.

  6. Digitization In Medical Device Manufacturing: 4 Priorities 9/14/2021

    Over the past year and a half, the global business disruption has created a sense of urgency around accelerating efforts to digitize and connect offline or siloed areas of operations. Most manufacturers see the benefits of digital transformation, but many don’t see the roadmap. Here are a few ways to apply digitization to enable agility and improve operations.

  7. Common Reasons For FDA Form 483 Observations And Warning Letters In Medical Device Environments 8/31/2021

    By understanding the FDA’s updated approach to medical device regulation and the information provided in the inspection observations document, medical device companies can more easily identify and mitigate compliance issues.

  8. ISO 13485 - Change? Do I Have To?? 8/31/2021

    Accordingly, many companies have a conundrum if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system. The array of opportunity may not be as broad in terms of rationalizing how to do business as an outlier.

  9. Metrics That Matter For Contract Manufacturing 8/27/2021

    For contract development, manufacturing, and packaging organizations, improving operational flexibility, increasing capacity, shortening lead times, and improving product quality is more important than ever.

  10. Most Common Reasons For FDA Form 483 Observations And Warning Letters In Medical Device Environments 8/26/2021

    When the FDA conducts regulatory inspections, issues that are considered objectionable conditions or compliance violations by FDA inspectors are itemized in a Form 483 or a warning letter. In this article, we help you understand the FDA’s updated approach to medical device regulation and provide information about inspection observations so you identify and mitigate compliance issues more easily.