• FY2018 Increasing User Fees Affects Submission Strategy

    11 October, 2017 by Michelle Lott, Founder, Lean RAQA Systems, LLC

    Just in the nick of time at the end of August, Congress reauthorized the Medical Device User Fees (MDUFA) ensuring that FDA received vital funding to properly staff submission reviews and other activities. While the user fees for all submissions increased, de novo submissions saw the most significant increase. Historically, de novo submissions did not have a user fee. However, with FDA’s expansion of the de novo submission options to include direct de novo rather than conversion from a non-substantially equivalent 510(k) determination, the FDA was understaffed to accommodate the additional review burden. As a result, de novo submission review times could drag out 10 to 12 months.

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  • Three Ways to Accelerate Your Lean Journey

    4 October, 2017 by Dan Markovitz, Founder, Markovitz Consulting

    I spent two days in St. Louis last week at the Global Lean Leadership Conference. It’s a small conference—only about 150 people—consisting of companies that have embraced Paul Akers’s 2 Second Lean philosophy. Companies that wanted to join the conference were required to have the president attend (although there were many other people from those companies as well).

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  • Anticipating Tensions Between Clinical Care and Study Protocol

    3 October, 2017 Laurie Meehan, Social Media Manager; Polaris Compliance Consultants, Inc.

    Protocol trumps practice. This principle seems clear enough, but complying with it is not always as straight-forward as it sounds. Years of practicing medicine has reinforced the way a physician responds to medical situations. But do these responses run counter to the investigational plan? Can a site’s commitment to standard of care affect its ability to meet enrollment targets? There’s a lot to consider.

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  • Canada’s Evolving Regulatory Landscape

    26 September, 2017 Raleigh Malik, PhD, Sr. Scientist, DIA

    Canada’s sesquicentennial marks a period of advancement and newfound transparency, where the past has set the stage for innovators to generate novel, yet safe and effective, health care products for Canadians. From the discovery of insulin at the University of Toronto in 1921 to the development of the first HIV preventative vaccine in 2013 (which is currently undergoing Phase II trials), Canada has a rich history of drug innovation. However, with health care product innovation comes government oversight and regulations required to ensure safe and effective treatments for the public.

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  • Coping with Scoping a CSV/Part 11 Audit

    21 September, 2017 by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    You use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply.

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  • Supply Chain Risk Management: An Ever-Changing Mosaic

    19 September, 2017 Geary W. Sikich, Principal, Logical Management Systems Corp.

    We have recognized the need to better manage supply chain risks for the nearly two decades now. Yet, we still seem to be deluded into thinking that the modern supply chain is resilient to the point of invulnerability.

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  • Medical Device Firms: 3 Tips for Jumping Over the Dossier-Management Hurdle

    14 September, 2017 by Cindy Fazzi, Staff Writer, MasterControl

    For medical device companies, the ultimate goal is to commercialize their products, usually in more than one market. The road to a successful product launch in multiple markets is full of obstacles and one of the biggest hurdles is dossier management.

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  • Understanding the Use of “Where Appropriate/As Appropriate” Within the ISO 13485:2016 Standard

    12 September, 2017 by Christine Park, Consultant, Christine Park & Associates

    Historically, the term “where appropriate” and/or “as appropriate” have been implied within the ISO 13485 standards as well as the FDA 21 CFR 820 Quality System Regulations. The FDA has always explained that “as appropriate” means it is appropriate unless you can justify why it isn’t appropriate.

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  • Rise of Digital Health Prompts FDA to Re-examine How It Regulates SAMD

    7 September, 2017 Jeffrey K. Shapiro, Director, Hyman, Phelps, McNamara, P.C.

    When you think about it, FDA's general regulatory paradigm for regulating medical devices has enjoyed a tremendous run. The overarching statutory and regulatory foundation was started in 1976 and largely in place in its current form by 1997. (Think 510(k)/MDR/Part 806 and QSR procedures for the postmarket phase.)

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  • Add Cybersecurity Education to Every Employee’s Job Description

    5 September, 2017 David Jensen

    The recent surge of security breaches and ransomware attacks is reinforcing the need to make cybersecurity an all-hands endeavor. Despite all the cybersecurity tools that companies are implementing, security breaches are still rampant because one of the top cybersecurity weaknesses in all industries is the lack of training employees on cybersecurity.

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  • Supplier Audits in Pharmaceutical Environments - Did You Know?

    5 September, 2017 MasterControl

    What is it that pharmaceutical manufacturers should do every 12-18 months? According to a recent FDANews update, pharmaceutical manufacturers should "conduct audits every 12 to 18 months for suppliers of critical materials," "perform a risk analysis to identify areas of concern for monitoring," and "negotiate quality agreements before signing a contract with a new supplier."

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  • ISO, Regulatory Requirement Changes Loom

    1 September, 2017 B. Christine Park, Consultant, Christine Park & Associates

    As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:

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  • EU Policy 70 and Redaction — PleaseReview’s Take on It

    1 September, 2017 by David Cornwell, Founder/CEO, PleaseTech Ltd.

    This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.

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  • Good Communication Skills are Key for Inspection Readiness

    25 August, 2017 UL

    When an FDA inspector comes to your door, it is usually a time of stress and uncertainty.  You need to handle logistical elements like where the inspectors are going to be placed, how you 

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  • Thoughts from 2017 PDA Quality Metrics and Quality Culture Conference

    24 August, 2017 by Stephanie Gaulding, CQA, CPGP, DPS Engineering

    I had the pleasure spending two days networking and discussing quality metrics and quality culture with industry and FDA leadership at PDA's 2017 Quality Metrics and Quality Culture Conference last February. This year's conference included some of the most candid and honest dialog on these topics that I've seen between industry and FDA to data. I thought I would share some of the messages and my takeaways from the two-day event.

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  • Avoiding CAPA Pitfalls: 10 Tips from a Food Industry Quality Expert

    22 August, 2017 by James Jardine, Staff Writer, MasterControl

    At a recent ASQ Salt Lake Section symposium held at the headquarters of quality management software solutions provider

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  • Nuts and Bolts of 510(K) Submissions

    17 August, 2017 by Rob Packard President, Medical Device Academy, Inc.

    A 510(k) is pre-market notification of medical devices to the US FDA. The number “510” refers to section of the Food, Drug and Cosmetic Act. “k” is the subsection specific to pre-market notification. Details regulating the process, however, are found in 21 CFR §807.

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  • What Is a Quality Control System and How Can an EQMS Improve On It?

    15 August, 2017 David Butcher, Staff Writer, MasterControl

    For organizations doing business in regulatory environments, successful quality assurance and quality control are crucial aspects of quality management in FDA- and ISO-regulated environments. Often, “quality control” and “quality assurance” are used interchangeably, referring to the activities conducted to ensure the quality of a product, service or process. While some quality control and quality assurance activities are interrelated, however, the two

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  • Regulatory Strategies for AI and Emerging Technologies

    14 August, 2017 by Steve Tyrell, Senior Director, Business Development, Regulatory Compliance Associates Inc. and Lisa L. Michels, General Counsel and Regulatory Affairs Expert, Regulatory Compliance Associates Inc.

    Insights on working with regulatory bodies on novel devices such as artificial intelligence, machine learning and algorithms.

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  • 6 Opportunities and Challenges Combo Product Makers Should Be Aware of in 2017

    8 August, 2017 by Alex Butler, Manager Medical Device Solutions, MasterControl

    Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that merge two or more different types of regulated drugs, medical devices or biologics into one multi-faceted treatment. As more device and pharma companies join forces to develop combo products, the traditional industry and regulatory boundary lines between the two sectors become blurred, presenting medical product makers

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