Regulatory Articles

71. Why Do Medical Device Businesses Fear Modern Electronic Documentation? 6/9/2015

    A variety of powerful, modern software tools exist for managing medical device product development documentation. The U.S. Food and Drug Administration (FDA) and other regulatory agencies have issued guidelines for the proper use of these solutions. So why are some medical device businesses hesitant to adopt them?

72. Risk Management EN ISO 14971:2012 – Implications For Medical Device Manufacturers 5/19/2015

    Risk Management is a fundamental step for medical device manufacturers to demonstrate compliance with the EU Directives for Medical Devices, ensuring the safety of patients and users. Since the advent of EN ISO 14971:2012, additional clarification within the standard has led to a number of misconceptions and confusion surrounding implementation. This white paper will help manufactures understand the changes made in EN ISO 14971:2012, and provides guidance on what is expected to comply with the standard.

73. GLPs And GMPs: When Are They Necessary? 4/24/2015

    Testing of FDA-regulated products may be performed under different regulations, including Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs). This white paper outlines the differences between GLP and GMP regulations that are significant to testing, and provides guidance on when these regulations are applicable.

74. Using TPP To Guide Medical Device And Diagnostic Development 2/25/2015

    Delve into how Target Product Profiles, a multidisciplinary strategic development process tool, can be adapted by medical devices and diagnostic programs for product development.

75. How To Develop A Quality Culture In Your Medical Device Manufacturing Operation 12/22/2014

    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.

76. The Sunshine Act: What Manufacturers, Clinical Professionals, And Researchers Need To Know 12/16/2014

    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.

77. How To Address The Top 3 Supplier Management Issues 11/5/2014

    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.

78. Biocompatibility of Anesthesia/Respiratory Products 7/31/2014

    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.

79. A Comparison Of Process Validation Standards 6/6/2014

    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.

80. Don't Use Last Century's QMS Tools For This Century's Medical Devices 5/14/2014

    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