Archive for the ‘Regulatory Compliance’ Category

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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
 

Morris Medical Monthly: How to use RiskPack (Part 3 of 4)

This entry is part 1 of 40 in the series Morris Medical Monday

Welcome back to Morris Medical Monthly: a monthly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.

Today we will start on the subject of Polarion’s RiskPack extension, and have a look into RiskPack’s Basics.

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2 years ago
 

Welcome to Morris Medical Monthly!

Welcome to Morris Medical Monthly. Wait… monthly? I thought it was Monday? Monthly is correct. You may have wondered why Morris Medical Monday has stopped. I’m change the schedule of posts about medical templates each month, so I can also provide content about extensions, conferences, whitepapers, etc.  (more…)

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3 years ago
 

Morris Medical Monday: Pain Relief for Medical Device Compliance Management

This entry is part 23 of 40 in the series Morris Medical Monday

With so many of our customers involved in the development of amazing new technologies and products in the medical field, we’re always interested to see stories like this recent one about a new implant technology that promises huge life quality gains for amputees.

According to this article, a revolutionary new technology being developed at London’s Royal National Orthopaedic hospital (RNOH) which recently completed a trial, allows artificial limbs to be attached directly to an amputee patient’s skeleton, giving them feeling and mobility far beyond that of today’s prosthetics. The the new implants, developed by the UCL/RNOH biomedical engineering institute and manufactured by Stanmore Implants, were inspired by research into how skin forms itself naturally around deer antlers. Although still in the trial stage, the prospect for wider roll-out should be good news for amputees.

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3 years ago
 

7 Steps to Meeting ITAR Requirements With Polarion

Lately, we’ve had an increasing number of inquiries about whether or not Polarion’s solutions are ITAR certified. The good news is that Polarion Software® doesn’t need ITAR certification to help regulated companies automate and accelerate their certification process. (more…)

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3 years ago
 

Traceability – 7 questions you need to ask to derive real value

Think about the following situation: You are near the end of your safety-related project, and you have established traceability between all the project artifacts. In an audit (e.g. Internal Quality Assurance, Customer, External Authority) you have to demonstrate which software requirements are developed from which system requirements. Each software requirement is linked to one or more system requirements, and any system requirement is also linked to one or more software or hardware requirements. You are in great shape for an audit – or are you?

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3 years ago
 

Morris Medical Monday: Polarion MedPack and Regulatory Compliance Part 4

This entry is part 12 of 40 in the series Morris Medical Monday

Welcome back to Morris Medical Monday: a weekly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.

Today we will continue on the subject of Polarion’s MedPack extension, and have a look into MedPack’s compliance support. (more…)

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3 years ago
 

Morris Medical Monday: Polarion MedPack and Regulatory Compliance Part 2

This entry is part 11 of 40 in the series Morris Medical Monday

Welcome back to Morris Medical Monday: a weekly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.

Today we will continue on the subject of Polarion’s MedPack extension, and have a look into MedPack’s compliance support. (more…)

by
3 years ago
 

Morris Medical Monday: Polarion MedPack and Regulatory Compliance

This entry is part 9 of 40 in the series Morris Medical Monday

Welcome back to Morris Medical Monday: a weekly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.

Today we will continue on the subject of Polarion’s MedPack extension, and have a look into MedPack’s compliance support. (more…)

by
3 years ago
 

3 Questions Medical Device Manufacturers Should Ask in the Hunt for Better Traceability

By Veijo Inkiläinen, Planmeca Group

Planmeca Group is a leading manufacturer of dental and mammography x-ray imaging and dental care products, with sales in more than 100 countries, since 1971. We make safe medical devices with outstanding clinical performance for patients and users.

Our operation is regulated by medical industry standards such as ISO 13485, ISO 14971, IEC 60601, IEC 62304 and by European Union medical device directives as well as U.S. FDA QSR laws. The Regulatory view to the operation of a medical device manufacturer can be simplified by asking 3 important questions. (more…)