Regulatory Articles

  1. UDI Impact on Medical Device Labeling: Lifting The Lid On Pandora’s Box

    Medical device companies are striving to capitalize on market opportunities while simultaneously dealing with increasing regulatory compliance requirements. One of the newer mandates, the FDA ruling on Unique Device Identification (UDI), requires action in three main areas.

  2. Beyond Compliance: Medical Device Product Development

    Increased regulatory scrutiny is a reality in today’s medical device industry. Over the last several years many of the industry’s leading companies have been hit with an injunction, undergone a product recall, or found themselves operating under FDA consent decree. At the same time, the pressure for growth on these companies has never been greater. Driven by Wall Street, the pace of new technology, emerging market opportunities, and competition from well funded start-ups, medical device executives find themselves in an environment where they must continually innovate with flawless execution to survive.

  3. CYA 101: 4 Tips to Help You Cover Your Audit

    Audits are a part of doing business for most life sciences companies, but that doesn’t make them any less stressful. If an audit goes badly, it’s a black eye for your company. You could be looking at long product delays, warning letters, consent decrees, recalls, or even a plant shutdown. So, what’s the secret to walking into an audit with confidence? It takes proper planning and the right tools. Here are a few tips to help you be better prepared, so you no longer have to fear the auditor.

  4. Due Diligence On Your Medical Device Manufacturing Partner

    A number of healthcare market forces – from cost pressures and global competition to strong demand from emerging nations – have converged to drive increasing use of design & manufacturing services companies to design, engineer, manufacture, package and distribute a wide range of medical devices.

  5. Software Development For Medical Devices

    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.

  6. The Multiplier Effect Of Drug-Device Convergence

    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.

  7. Why Do Medical Device Businesses Fear Modern Electronic Documentation?

    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?

  8. Risk Management EN ISO 14971:2012 – Implications For Medical Device Manufacturers

    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.

  9. GLPs And GMPs: When Are They Necessary?

    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.

  10. Does Your CAPA System Need A CAPA? Automating Corrective And Preventative Actions In The FDA Environment

    FDA requires manufacturers to have a corrective action and preventive action (CAPA) process to address and mitigate the impact of deviations and nonconformances. A review of FDA warning letters indicates that some companies think of CAPA only after quality issues have emerged; others have CAPA systems, but they are inadequate. How does your organization handle CAPA? This white paper will discuss why medical device manufactures need CAPA and how to choose the right tools when you are establishing a new CAPA process or improving an existing one.