Regulatory Articles
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Software Development For Medical Devices
7/10/2015
Software is fast becoming the differentiator for manufacturers of medical devices. The rewards of software innovation are balanced by the risks and challenges of regulation, stringent quality requirements, market pressures, and significant complexity.
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The Multiplier Effect Of Drug-Device Convergence
6/23/2015
First-generation drug-device pioneers could not have envisioned today’s landscape. The growing convergence between medical devices, pharmaceuticals, and biologics is transforming these once-separate market sectors, not to mention the state of health care and our quality of life. The global market for drug-device combinations is on track to generate $115 billion in market value by 2019. Thus, opportunity — and demand — abounds for effective treatments combined with innovative drug delivery methods.
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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?
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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.
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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.
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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.
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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.
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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.
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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.
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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.