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Articles written by John Gagliardi

FDA Works to Modernize 510(k) Process, Takes Aim at Predicates, De Novo Pathways

by John Gagliardi | Jan 2019

This more modern 510(k) pathway is to be used for clearance of low- to moderate-risk devices. It has a focus on predicate devices that are 10 years old or less, and its framework is aimed at efficiently advancing beneficial technology to patients while keeping with FDA’s standards for safety and e ... Read more »

FDA Priorities: People, Simplicity and a Risk-Based Approach to Speed Time to Market

by John Gagliardi | Dec 2018

By utilizing a more straightforward methodology, FDA can free up and better use resources to focus on high-risk areas that have the biggest impact. "Simplicity requires that FDA remain limber," writes John Gagliardi. "For industry to be innovative, the federal government must be innovative as well." ... Read more »

25 Considerations for Companies Seeking Clarity in Design Controls

by John Gagliardi | Sep 2018

OEMs must be aware of and comply with design control requirements included in 21 CFR, Part 820. Unsafe, ineffective devices are often the result of informal development that does not ensure proper establishment and assessment of these requirements.  ... Read more »

Think Different About Management Reviews

by John Gagliardi | Jun 2018

When done correctly—with preparation and an energized approach—these reviews can complement strategic planning and measure the effectiveness of your QMS in relation to your business model. ... Read more »

FDA and Customs Monitoring of International Purchasing: What You Need to Know

by John Gagliardi | Apr 2018

The ultimate goal is to ensure that all medical device products manufactured or distributed in the U.S. are both safe and effective for human use.  ... Read more »

The Medical Device Labelling Process Needs to Start Early in Design Controls

by John Gagliardi | Feb 2018

Mislabeled and misbranded medical devices are one of the top three causes for recalls in the United States. Companies can take several steps to minimize these mistakes — it comes down to being in control. ... Read more »

Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies

by John Gagliardi | Dec 2017

While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA named it an official program earlier in 2017.    ... Read more »

CAPA Notes from an FDA Inspection

by John Gagliardi | Oct 2017

Corrective and Preventive Actions or CAPA touches nearly every process in the Quality Management System (QMS). Read insight gained by John Gagliardi while participating in the interactions between the inspector and the medical device manufacturer. ... Read more »

Device Recalls: Prepare for the Unexpected to Minimize Operational and Fiscal Damage

by John Gagliardi | Jun 2017

While no company expects to undergo a FDA recall, preparatory steps can decrease the costly and lengthy process of removing product from the market. Begin by knowing the leading causes of recalls. ... Read more »

Don't Treat Your FDA Inspection Like an ISO Audit

by John Gagliardi | May 2017

Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each other with respect to medical device manufacturing and design quality systems. Despite the similarities, it is the interpretation and the approach of the investigator or the auditor that makes the experience very different.& ... Read more »

A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens

by John Gagliardi | Jan 2017

Our global industry requires companies to develop harmonized postmarket surveillance systems that minimize inconsistencies in our understanding of product lifecycle risks. ... Read more »

Building Your Bridge to the Island of ISO 13485:2016

by John Gagliardi | Nov 2016

Medical device companies have until March 1, 2019 to update their quality management systems to the ISO 13485:2016 standard. The simultaneous introduction of the Medical Device Single Audit Program and transitions to ISO 9001:2015 will leave manufacturers busy and certification bodies slammed. There ... Read more »

Resubmitting a 510(k) is More Than a Regulatory Decision

by John Gagliardi | Sep 2016

Do changes to your device warrant a 510(k) submission? There are several elements to consider: design controls compliance, risk analysis and postmarket surveillance data, among them. ... Read more »

Third Party Reviews – Is This the Real Deal?

by John Gagliardi | Jun 2016

Companies with simpler products like arthroscopes and surgical instruments could consider a regulatory route that doesn't start with FDA and instead utilize the Third Party Review program. The benefits to doing so include speeding time to market and saving time and resources for more complex 510(k) ... Read more »

Supplier Quality Agreements Are Not Just a Handshake Anymore

by John Gagliardi | Apr 2016

Regulatory bodies do not see supplier quality agreements as a new requirement. They also expect medical device manufacturers to require suppliers to conduct remediation where required and within documented timelines. It is appropriate to use a risk management approach to prioritize required focal po ... Read more »

The Revitalized ISO 13485: Ready for Business

by John Gagliardi | Feb 2016

The ISO 13485:2016 Standard is slated for publication in March 2016. Consider these eight changes when updating your certification.The internationally-recognized medical device industry quality management systems (QMS) standard has been under revision since 2010. The newest version of ISO 13485 (201 ... Read more »

8 Design Control Issues Found During FDA Inspections

by John Gagliardi | Nov 2015

Involvement with numerous FDA inspections over the years has given me, I think, a unique perspective on design control trends—specifically, major design issues discovered during FDA inspections. ... Read more »

Manufacturing or Selling Medical Devices in Mexico: A Regulatory Conundrum

by John Gagliardi | Oct 2015

Mexico is making significant steps on in-roads into the medical device industry and is ready for success. Industry analysts predict that the fabrication and selling of medical devices and related technologies will increase 75 percent over the next decade. ... Read more »

Purchasing Controls: Draft the Best Supplier Quality Agreement

by John Gagliardi | Jul 2015

Quality agreements are an essential management tool to prevent supply chain problems. The best contracts clearly define the extent of control exercised over products, services, suppliers and sub-tier suppliers. ... Read more »

How to Avoid Risky CAPA Decisions

by John Gagliardi | Mar 2015

When non-conformity is identified, your company must determine the significance, the associated risk and the potential for recurrence. Manufacturers must determine a common denominator that helps with the decision-making. ... Read more »

Compliance Isn’t Accidental: A Case for Management’s Commitment to Quality

by John Gagliardi | Jan 2015

Leadership must foster a culture of business and quality equilibrium to drive long-term product and company success. That commitment involves proper planning, employee training and performance measurement. ... Read more »

Why Won’t My CAPA Process Work?

by John Gagliardi | Dec 2014

Having a viable CAPA process in place is critical, in a time of frequent recalls, increased warning letters for repeat offenders and burdensome reporting requirements. ... Read more »

FDA Seeks 21st Century Agility with 510(k)s

by John Gagliardi | Oct 2014

FDA introduced several changes, including new initiatives to clarify the 510(k) submission process. How will these changes affect your device’s pathway to market clearance? ... Read more »

The Starting Line: Turning the Corner with a Device Concept

by John Gagliardi | Jul 2014

New orthopaedic device concepts from surgeon entrepreneurs and novice inventors often hit snags when facing the reality of the regulated industry. Understanding the barriers in each step of commercialization yields a more successful outcome. ... Read more »

Design Controls: A 17-Year Learning Curve

by John Gagliardi | May 2014

Developing a new device and introducing it into production are very complex tasks. Thorough planning, process control and design controls are essential to ensure that errors and important aspects aren’t left undone. ... Read more »

Synergetic Dissimilarity: Design Validation/Verification and Process Validation

by John Gagliardi | Mar 2014

Verification and validation are commonly confused. John Gagliardi defines the intertwined engineering tools and outlines how they are practiced. ... Read more »

Postmarket Surveillance and Vigilance: Making Risk-based Decisions

by John Gagliardi | Dec 2013

Medical device risk management is not a one-time project. Implementing the following steps will ensure review and risk assessment takes place throughout the life of the device. ... Read more »

Risk Management: The Science of Minimizing Uncertainties

by John Gagliardi | Oct 2013

The success of a risk management process in medical device manufacture lies in an early start in design and use of the life cycle approach in continuum. Here is how to establish, document and maintain risk management procedures. ... Read more »

India Considering New Device Regulations

by John Gagliardi | Aug 2013

With an evolving regulatory situation, medical device companies must stay up-to-date in order to achieve success in India. Orthopaedic OEMs should take the following steps to gain share in what will soon be the most populated country in the world. ... Read more »

China Becomes Vastly Improved Player

by John Gagliardi | Jul 2013

China’s medical device market is growing fast and the competition is fierce. Companies looking to enter the market or expand their business need to understand the changing industry. ... Read more »

Design Control Hot Buttons to Expect During an FDA Inspection

by John Gagliardi | May 2013

FDA evaluates the methods and procedures that a manufacturer has established to implement design control requirements. During an inspection, attention is turned to these design linkages. ... Read more »

Just Because You’re Trained, Doesn’t Mean You’re Competent

by John Gagliardi | Apr 2013

Orthopaedic device manufacturers must define the requirements for each job, evaluate the people in those jobs, develop a gap examination for each person and then create a plan to close those gaps. ... Read more »

Passing Brazil’s Inspections to Take Product to Market

by John Gagliardi | Jan 2013

Over the past few years, I have had the opportunity to help orthopaedic medical device companies prepare for and logistically manage inspections conducted by ANVISA. This article explains the Agencia Nacional de Vigilancia Sanitaria foundation upon which the regulatory framework is established, and ... Read more »

The Quality Review Board: A Conduit for Success

by John Gagliardi | Dec 2012

Your Quality Review Board exists to ensure continual improvement to your Quality Management System. How do they stack up as a conduit for the success of your company’s directives? ... Read more »

Complaints: A Second Chance to "Make it Right"

by John Gagliardi | Oct 2012

Customer complaints can give medical device companies a wake-up call when they're not achieving their fundamental purpose: that is, meeting customer requirements. If orthopaedic companies don't deliver what they promise, i.e. meet the customer's requirements (the root cause of most complaints) the c ... Read more »

Quality by Design: Incoming Acceptance Activities of Purchased Materials

by John Gagliardi | Aug 2012

All manufacturers of orthopaedic medical devices must establish and maintain procedures to verify that all products meet their specifications and acceptance criteria. Acceptance activities can include, but are not limited to, inspection and testing, the use of certificates of analysis, supplier audi ... Read more »

The Anatomy of a Warning Letter, Part Two: Excerpts and Response Strategies

by John Gagliardi | Jun 2012

This is the second of two articles dealing with the FDA Warning Letter, in which we’ll look at actual letter excerpts with recommended strategies to respond to FDA in a compliant and effective manner. As discussed in the prior article (See BONEZONE, March 2012), when FDA finds that a manufacturer ... Read more »

The Anatomy of a Warning Letter, Part One: A Primer

by John Gagliardi | Mar 2012

This is the first of two articles dealing with the dreaded Food & Drug Administration (FDA) Warning Letter. This first article is an introduction, if you will, to Warning Letters. The second article will contain actual warning letter excerpts with a recommended strategy to respond to FDA in a co ... Read more »

Planning for the Unpredictability of Change

by John Gagliardi | Dec 2011

...and it Begins   Change, defined: The act, process, or result of altering or modifying  Change is inevitable and sometimes even predictable but, then again, that depends. If you’re an orthopaedic device company obligated to follow the edicts of 21 CFR, Part 820 and ISO 13485:2003, t ... Read more »

The Internal Quality Audit Process for Orthopaedic Medical Device Companies: Risk Indicators and Uncertainties

by John Gagliardi | Aug 2011

FDA analysis of factory inspections has shown that manufacturers who do not have an adequate quality audit system usually do not have an adequate quality system. An evaluation of approximately 2,400 manufacturers that received cGMP-QSR inspections by FDA showed that manufacturers with an adequate qu ... Read more »

Corrective and Preventive Action: What Does FDA Look For During Inspection?

by John Gagliardi | Mar 2011

This is a first of a series of articles addressing the topic of what FDA seeks during an inspection. This article also serves to introduce my lecture and workshop scheduled for OMTEC 2011, relative to FDA inspections. (Further details are available following this article.) The orthopaedic industry ... Read more »

Design Controls: Design Transfer, Changes and the Design History File

by John Gagliardi | Dec 2010

In this issue, we wrap up a series of six articles focused on the design controls process from a standpoint of design transfer, changes and the design history file (DHF) in the orthopaedic medical device marketplace. I hope that you have enjoyed reading the previous articles, which are all available ... Read more »

Design Controls: Design Verification and Validation

by John Gagliardi | Sep 2010

This editorial is the fifth in a series of six articles focused upon the design controls process from a standpoint of design verification and design validation in the orthopaedic medical device marketplace. First, let’s review some pertinent definitions of terms from the 21 CFR, Part 820.30 and IS ... Read more »

Design Controls: Design Review

by John Gagliardi | Jun 2010

This is the fourth in a series of articles focused on the design controls process from a standpoint of business acumen as well as meeting customer requirements in the orthopaedic medical device marketplace. Because the design process is controlled and driven by a cross-functional group of individual ... Read more »

Design Controls: Inputs and Outputs in Synergy

by John Gagliardi | Mar 2010

This is the third in a series of articles focused on the design controls process from a standpoint of business acumen as well as meeting customer requirements in the orthopaedic medical device market. Sometimes called the requirements phase, design inputs are the starting point of understanding the ... Read more »