Regulatory Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  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. 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.

  10. EU MDR: How To Prepare for The Upcoming Changes In Regulation 8/24/2021

    Recognizing the need to enforce heightened safety measures and risk management processes, the European Parliament and the Council of the European Union developed the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in 2017.