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Articles written by Robert Packard

Top Tools to Qualify Suppliers

by Robert Packard | Jan 2017

When an OEM specifies weak second-tier suppliers, its first-tier suppliers have fewer resources to devote to its own internal processes. One weak link can prevent the best outcome from occurring. This six-step program helps OEMs ensure that they’re recommending top suppliers throughout the chain. ... Read more »

ISO 9001 Drastically Revised

by Robert Packard | Aug 2015

The ISO 9001:2015 standard is a major revision that will require significant time and resources to determine the best way to implement the revised quality system. Most companies will need all three years of the transition period for compliance. ... Read more »

Big Changes in ISO 13485:2015?

by Robert Packard | May 2015

On February 5, 2015, a second draft of ISO 13485 was released to the world for comment. How will new quality system requirements in the latest version of ISO 13485 affect you? ... Read more »

The Basics: Understanding the Medical Device Single Audit Program

by Robert Packard | Feb 2015

MDSAP was launched to leverage resources of regulatory bodies in the U.S., Canada, Brazil and Australia to monitor device manufacturers. Here is a breakdown of how the pilot program works and each country’s participation. ... Read more »

Six Ways to Prevent Supplier Quality Problems

by Robert Packard | Jun 2014

The root cause of defective product from suppliers is often inadequacies of your own supplier controls. The methods described in this article will help you prevent supplier quality issues that could result in a 483. ... Read more »

Sterilization: How to Validate Novel and Non-Traditional Processes

by Robert Packard | Apr 2014

Novel and non-traditional sterilization processes offer alternatives that enable manufacturers to consider new polymer materials that are not compatible with traditional sterilization methods. Here is a look at the tools and standards for sterilization validation. ... Read more »

Five Ways to Prevent Complaint Handling Pitfalls

by Robert Packard | Mar 2014

Learn how to avoid receiving 483s from other's previous mistakes. This article analyzes the five most common 483s related to 21 CFR 820.198, reviews what FDA inspectors typically find that results in a 483 and what FDA inspectors hope to find. ... Read more »

Auditing Process Validation & Developing Protocols

by Robert Packard | Jan 2014

Have you ever had to perform a process validation protocol for a new piece of equipment or acquired a process that was not properly validated? If not, consider yourself lucky. For when the task does arise, here is how to perform a process validation audit and develop a protocol. ... Read more »

Start Early: Converting Your Spinal Technical File into a Class III Design Dossier

by Robert Packard | Dec 2013

As part of EU Commission regulatory changes, spinal implants will be reclassified from Class IIb devices to Class III devices. OEMs with spinal implants on the market should be proactive and start planning for reclassification now. ... Read more »

Device Company Questions Answered

by Robert Packard | Dec 2013

Here are a few regulatory and supplier questions that Rob Packard fielded at OMTEC 2013 from people just like you. He’s coming back in 2014. Get your questions ready. ... Read more »

How to Build a Better Supplier Scorecard

by Robert Packard | Nov 2013

Supplier scorecards are intended to be a simple tool to help you evaluate suppliers. These steps provide for an easier and more efficient process. ... Read more »

The Anatomy of a Successful Design Plan

by Robert Packard | Oct 2013

Did your latest project plan end with another line extension and the cold reality that your team was eight weeks behind? These six steps will allow you to master the design and construction of medical device design planning. ... Read more »

How to Avoid Major FDA Inspection Mistakes

by Robert Packard | Jul 2013

Don’t let these details get lost in the preparation and follow up for FDA inspections. ... Read more »

Seven Ways to Investigate Complaints When Devices Aren’t Returned

by Robert Packard | Jun 2013

One of the challenges in product complaint handling is making sure you’ve done enough when you’re unable to verify the complaint. These steps lead to a successful investigation process. ... Read more »

Six Steps to ISO 13485 Certification

by Robert Packard | May 2013

ISO 13485 Certification is the quickest pathway to achieving CE Marking approval. Manufacturers should follow these sequential steps as a roadmap to certification. ... Read more »

What if Your ISO Auditor is Wrong?

by Robert Packard | Apr 2013

Auditors are human. The question is: What should you do when they're wrong? ... Read more »

Lessons Learned From Metal-on-Metal Implants

by Robert Packard | Mar 2013

The FDA is only the latest regulatory body to take investigative action on metal-on-metal implants. What follows is a two-part primer on metal implant test method results and risk analysis steps OEMs should consider as fallout continues over the use of MoM implants. ... Read more »

Develop Orthopaedic Implants Faster Through Auditing

by Robert Packard | Feb 2013

Do your auditing techniques actually improve product development? These three techniques—one simple, one advanced and one new—will shorten the cycle. ... Read more »

Six Steps to Qualifying Suppliers

by Robert Packard | Jan 2013

If an OEM specifies weak second-tier suppliers, its first-tier suppliers will have fewer resources to devote to its own internal processes. One weak link can prevent the best outcome from occurring. This six-step program helps OEMs ensure that they’re not recommending inferior suppliers anywhe ... Read more »

Strategic Planning for Regulatory Compliance

by Robert Packard | Dec 2012

Will you wait until your company has an unannounced audit by a Notified Body? Or will you develop a Quality Plan to prepare for these changes? The principles in this article apply to all medical device manufacturers, any device and every new and revised regulatory requirement. The purpose of th ... Read more »