Rob Packard

Did your latest project plan begin with a bold idea and the hope to fill your booth at AAOS with innovation and excitement?

Did that project plan end with another line extension and the cold reality that your team was eight weeks late for the biggest event of the year?

Your project didn’t need to end that way, but you can console yourself in knowledge that most of your competitors had projects that slipped just past the deadline, too. If you want something to cheer about next… Show more

Did your latest project plan begin with a bold idea and the hope to fill your booth at AAOS with innovation and excitement?

Did that project plan end with another line extension and the cold reality that your team was eight weeks late for the biggest event of the year?

Your project didn’t need to end that way, but you can console yourself in knowledge that most of your competitors had projects that slipped just past the deadline, too. If you want something to cheer about next year, you need to master the design and construction of medical device design planning. Every manufacturer must make design planning a core competency for survival. Show less

Clinical data is required for all submissions of pre-market approval (PMA) and for more than ten percent of 510(k) pre-market notifications to FDA. Clinical data is also expected in Europe as part of the CE marketing approval process of most Class III devices, and many Class IIb devices. One of the essential requirements for CE Markings is that, “Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended.” In addition, under the Medical Device… Show more

Clinical data is required for all submissions of pre-market approval (PMA) and for more than ten percent of 510(k) pre-market notifications to FDA. Clinical data is also expected in Europe as part of the CE marketing approval process of most Class III devices, and many Class IIb devices. One of the essential requirements for CE Markings is that, “Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended.” In addition, under the Medical Device Directive (MDD) and the Active Implantable Medical Device (AIMD), CE Marking requires a clinical evaluation for all devices as part of the submission for CE Marking and thereafter. Show less

On May 16 of 2012, the European Committee for Standardization (CEN) approved a revised European National Standard for medical device risk management: EN ISO 14971:2012. There were no changes to the main body of the Standard (i.e. – Clauses 1 through 9). Instead, the revised European National (EN) version identifies seven deviations in Annex ZA, ZB, and ZC with respect to the intent of the MDD, the AIMD, and IVDD respectively

FDA inspections strike fear into most companies, but most of the fear is due to a lack of knowledge about what to expect from the FDA. Therefore, the person responsible for the design control process at your company should read two important documents—in addition to this article:

The Quality System Regulation (QSR) Preamble (http://bit.ly/QSRpreamble) – specifically pages 52615-52622 (8 pages)
The Quality System Inspection Technique (QSIT) Manual (http://bit.ly/QSITManual) –… Show more

FDA inspections strike fear into most companies, but most of the fear is due to a lack of knowledge about what to expect from the FDA. Therefore, the person responsible for the design control process at your company should read two important documents—in addition to this article:

The Quality System Regulation (QSR) Preamble (http://bit.ly/QSRpreamble) – specifically pages 52615-52622 (8 pages)
The Quality System Inspection Technique (QSIT) Manual (http://bit.ly/QSITManual) – specifically pages 32-45 (14 pages) Show less

FDA has decreased the length of time between inspections in recent years, thus requiring medical device companies to be prepared to accommodate the inspector’s more frequent visits and quickly respond to possible findings.

An OEM may receive dozens or even hundreds of product quality complaints each year. During a recall, there may be hundreds of complaints per month. One of the greatest challenges in complaint handling is making sure that you have done enough when you are unable to verify the complaint. What do you do when you receive a complaint, but are unable to verify that the complaint actually involved a device malfunction?

People frequently ask me where to find information about ISO 13485, but I always have trouble finding resources specific to certification. Therefore, I recently completed a white paper specific to ISO 13485 certification, and this article provides a brief overview of the sequential steps to the process.

Imagine completing your first ISO Certification audit. Your company received no major nonconformities, but the auditor identified a bunch of minor findings. You expect to receive a recommendation for certification, but instead the auditor says, “There were eight minor nonconformities, and therefore I cannot recommend certification.”

Months ago, the idea came to me to write three articles about the lessons learned from metal-on-metal (MoM) implants. My intent was to have three authors write about three important aspects of designing orthopaedic implants: verification test methods, risk analysis and post-market surveillance.

Most auditors pretend to “add value.” Adding value is a cliché. In this article, you will learn three auditing techniques that actually improve product development (or any process). The first tool is a simple auditing technique that most auditors know, but forget to use. The second is an advanced technique that auditors don’t always learn. The third tool is probably completely new to auditors.

Imagine that you are a QA consultant. Last night you wrote a blog about the three tools needed to qualify suppliers. Today you are auditing a supplier, and have just complimented the purchasing manager on his quality program. During lunch, Kim, the general manager, says, “Michael was just showing me the blog you wrote about how to qualify suppliers. I was confused—your blog seemed to say that we are doing everything wrong, but you just told us that our supplier quality program looks great.”

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 this article is to illustrate best practices in strategic planning for companies.