Archive for Author Larry Sampson, Author at Polarion Software Blog

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7 months ago
 

Internet of Things: Creating Challenges for Medical Device Manufacturers

We recently posted “Internet of Things: Expanding Into Medical Device Enterprise,” and welcome you to part two of the ongoing discussion about medical devices and the Internet of Things (IoT).

Realization

Because field update of software is possible for hardware that is no longer manufactured it is now probable that more than one DMR will be approved for use with the variety of different product configurations (hardware and software variants).  In addition to this an update of the product in the field requires the DHR not be a static lot based document.  It is now time based.

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7 months ago
 

Internet of Things: Expanding into Medical Device Digital Enterprise

What is the definition of the Internet of Things (IoT)?

Gartner defines IoT as the following: “The Internet of Things (IoT) is the network of physical objects that contain embedded technology to communicate and sense or interact with the internal states or the external environment.”

If a medical device firm is implementing an IoT device, implied in the definition is a set of new product features related to the company ideation, realization and utilization systems. We will begin with a delineation some of the new capabilities and potential features IoT promises to bring to our devices.

This list will be fairly short to illustrate the difficulty in implementing this kind of technology, and the need for a digital model to support the effort not only in creation of the product, but just as critical, in management of the device after deployment.

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12 months ago
 

Medical: A Risk Management Data Model

In our previous blogs I described [blog 1] and [blog 2] the regulatory requirements related to product risk and the elements required to build a database for use in the risk management system. The following is a discussion of the risk management data model and how the evaluation of risk can be accomplished using the design control previously discussed.

ISO 14971 Annex E characterizes the relationship between elements in the analysis of risk with the following flow chart:

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12 months ago
 

Medical: A Traceability Data Model

To read the first blog in this series, Comprehensive Medical Device Risk Management, please click here. 

The first task of any product development process is generally to discover, define and link the items of interest for that product. This is best accomplished in a logic Flow Diagram, and is the basis for developing the Design V&V test plan, and risk Management framework. One example of such a diagram is the Polarion medical device template comprehensive traceability table (shown below).

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1 year ago
 

Comprehensive Medical Device Risk Management

One of the more difficult system development tasks in the context of a new medical device is how to organize and develop the product risk management strategy. When contemplating how to construct a system to manage this task, it’s necessary to consult not only company work flows and processes, but standards adopted by the competent authorities meant to standardize how medical device products are developed and approved.

Standards

At the time of this writing, the two standards used in definition and implementation of medical device risk management are ISO 14971:2009 and TIR 24971:2013. Europe has added to the mix by approving an EN ISO version of 14971, which is EN ISO 14971:2012. The EN version is different in several important aspects, and is required if the company is selling into Europe. (more…)

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1 year ago
 

Medical Device System Software Validation Documents

As I discussed in my last blog, software used as a platform to support the manufacture of product or in the product quality management system (QMS) must be validated (as required by 21 CFR §820.70(i)). The process is the same process used to develop design controls for a medical device without the requirement for compliance with ISO 62304 [white paper: Achieve Fast Compliance with IEC 62304]. Larger medical device firms usually assign this task to their IT department.

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1 year ago
 

Medical Device Software Validation Terminology

To read the first blog of this series, Cloud Computing and Software Validation, please click here.

I was recently speaking with a colleague about the significant software validation burden on life science companies. I found it interesting how difficult it was to sort out our terminology. It turns out that the regulatory agencies – and the Food and Drug Administration (FDA) in particular – have not been consistent in the application of language and definitions.

This confusion adds to the growing complexities that organizations with required FDA oversight might find challenging. I thought it might be valuable to spend some time discussing the various terms to better provide a common reference point.

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1 year ago
 

Cloud Computing and Software Validation

One of the more difficult problems associated with the introduction of cloud computing is a constant need for software validation of platform software changes.

Many of Polarion’s clients use our software in the verification and validation (V&V) of product software, but equally important, our product is very well suited for onboarding what the Food and Drug Administration (FDA) terms “Automated Processes” as defined in 21 CFR §820.70(i).

These are systems developed for “When computers or automated data processing systems are used as part of production or the quality system, …”. Examples include Product Life Management (PLM), Enterprise Resource Planning (ERP), custom production applications, and in some cases even the company web site if it is used for dissemination of company documentation to customers.

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1 year ago
 

An Insight to Truth

For some time document management, PLM, and ERP systems have been banging the drum of becoming the company single source of truth.  I would like to take a different approach and discuss the data management from a framework of an insight to truth. This approach is agnostic to where data is stored, and specific to how it is defined, processed, and presented to stakeholders for management of the product. The following is a flowchart of a typical company risk management process. (I will present a comprehensive view of Medical Device Risk Management in an upcoming blog post.)

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2 years ago
 

Medical Device Design Control (Part 3 of 3)

This entry is part 1 of 3 in the series Medical Device Design Control

Medical device product development work is a highly integrated, and regulated process. Implementation of a requirements tracking solution requires attention to a variety of nuanced topics. In this 3-part series, we present a practical approach derived from real-world experience developing medical devices using Polarion solutions. In this third and final installment, we look into Document Definition. (more…)