Regulatory Articles

  1. Performance Test According To Chapter 2.1.7 Of The Ph. Eur. 7/21/2023

    This operating procedure describes how to perform a repeatability and sensitivity test according to Chapter 2.1.7. of the European Pharmacopoeia.

  2. Repeatability Test With External Test Weights 7/20/2023

    A repeatability test with external test weights is one of the recommended tests to ensure balances are working correctly. This operating procedure describes how to perform a repeatability test with external test weights.

  3. Reduce Human Error In Healthcare Operations And Medical Equipment Management 4/20/2023

    Implementing an IoT platform powered by RFID enables clinicians to effectively use medical equipment and reduce human error in healthcare processes to ensure higher quality of care.

  4. Containment Solutions To Help Emerging Biologic Companies 3/24/2023

    Set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.

  5. The Dynamic Regulatory Environment Of Drug-Device Combination Products 11/29/2022

    Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.

  6. Biological Indicators And The European Pharmacopoeia 5/10/2022

    Here, we review the information concerning biological indicators in European Pharmacopoeia General Chapter 5.1.2, which is more detailed and covers a wider scope than the previous version.

  7. Medtech Manufacturing: From Disruption To Evolution 12/16/2021

    Medical device manufacturing is a complex industry, so figuring out what areas to digitize can be difficult and different for every company. Here we explore different ways medical device and diagnostic manufacturers are embracing digital tools to maximize the value of ever-increasing data, as the industry pivots from crisis mode to evolution.

  8. 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.

  9. How Digitization Is Delivering Competitive Advantage In Device Assembly 9/20/2021

    Data and the digitization of assembly equipment work to deliver a competitive advantage to pharma partners in terms of quality, continuous improvement, de-risking maintenance, and change management.

  10. 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.