Regulatory Articles

  1. How To Develop A Quality Culture In Your Medical Device Manufacturing Operation

    The lengths to which medical device companies go to deliver a quality product vary widely, but clearly there are some commonalities with regard to the development and maintenance of a quality management system that produces consistently excellent products. One of these has to do with the amount of attention given to manufacturing operator and technician training.

  2. The Sunshine Act: What Manufacturers, Clinical Professionals, And Researchers Need To Know

    The Sunshine Act requires that research payments made to physicians and teaching hospitals be reported to CMS. This includes payments and grants in support of basic and applied research and product development. CMS began publically displaying the payment information starting in the fall of 2014. Practically speaking, manufacturers should invest the time in understanding this new and complex regulation. Failure to do so may result not only in fines and bad publicity but also in harm to relationships with customers.

  3. How To Address The Top 3 Supplier Management Issues

    Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency — in terms of time, cost, and quality. Unfortunately, suppliers can also sometimes put their clients in hot water when their quality standards are below par. With over 12 years of experience in medical device development, I understand how hard it is to find and keep compliant suppliers. Based on my observations working with suppliers in the medtech industry, these are some of the major issues that impact a device manufacturer’s compliance efforts.

  4. Certification: Is It Worth The Hassle?

    In the life sciences and other regulated industries, obtaining certification in a range of international standards has become a necessity for companies hoping to access and compete in today’s global marketplace. Whether your organization is a laboratory, medical device manufacturer, or automobile maker, becoming certified by an impartial third-party accreditation body assures potential customers that you value quality and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages. But certification can be a long and trying process. By Lisa Weeks, Marketing Communications, MasterControl

  5. Biocompatibility of Anesthesia/Respiratory Products

    This biocompatibility technical whitepaper is a reference guide for navigating aspects of the various biocompatibility standards for respiratory devices. It is intended to aid design engineers in understanding the complexity of biocompatibility standards as applied to anesthesia workstations, ventilators, and oxygen concentrators.

  6. Managing Risk In Medical Connectors

    This paper will help to educate designers and manufacturers of medical devices who integrate electrical connectors into their design on some recent changes made by the FDA, and the implications of the new regulations.

  7. A Comparison Of Process Validation Standards

    U.S. life science firms are currently subject to two different process validation standards: the Global Harmonization Task Force’s Process Validation Guidance and FDA’s Process Validation: General Principles and Practices. These standards have considerable overlap, both officially and practically, across the drug and medical device industries. Previously, all FDA divisions followed a single guidance document, but that document has long since been superseded by new regulations and advances in validation science. This article examines the differences and similarities between the two guidance documents and concludes that any firm manufacturing product whose predicate regulations require process validation (drugs, devices, Active Pharmaceutical Ingredients, biologics, or human-based tissues) should incorporate the philosophies and directives of both to meet Agency expectations and to assure the highest quality of their products. By Jeff Boatman, senior subject matter expert, medical devices and quality systems, QPharma Inc.

  8. Don’t Use Last Century’s QMS Tools For This Century’s Medical Devices

    It goes without saying that a well organized and auditable quality management system (QMS) is job number-one for medical device manufacturers. However, a surprising number of organizations are still using Microsoft Office — specifically Word and Excel, both of which were invented in the 1980s — to manage their quality and design systems. By Steve Chalgren, Arena Solutions

  9. What Exactly Is The Cloud?

    What exactly is Cloud? Or is it, The Cloud? Is it just me, or do no two people describe it the same way? As the product manager over the Cloud initiative at MasterControl, I hear these kinds of questions all of the time. With all of the advertising, mixed messaging, technical jargon, and promises of grandeur, it’s easy to see why so many consumers are confused. At its heart, the term Cloud has been a powerful marketing turn-of-phrase that has consolidated a large mix of technologies. By Victor Gill, MasterControl Inc., Senior Product Manager of Cloud Solutions

  10. New Draft Guidance On Quality Agreements: No Passing The Buck On CGMPs

    Last month, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with manufacturing activities in a manner that is consistent with regulatory requirements. By Cathy L. Burgess, Donald E. Segal and Guillermo Cuevas, Alston & Bird LLP