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Category: medical device

Focus on the Latest Regulatory and Risk Management Requirements for Medical Plastics

Posted on 19 September 2021 (29 March 2023) by tim
Regulatory and Risk Management Requirements for Medical Plastics

Here are the new, key regulatory and risk management requirements for plastics and additives used in medical devices, from design all the way to use.

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Posted in medical device, regulations, risk management, Uncategorized

How to Reduce Risk As Far As Possible

Posted on 23 July 2021 (25 July 2021) by tim
Reducing Risk

How to identify and analyze risk control options and implement those risk control measures that reduce risk as far as possible, without adversely affecting the benefit-risk ratio.

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Posted in medical device, regulations, risk management, UncategorizedTagged EU IVDR, EU MDR, regulations, risk, risk management

European Union Medical Device Regulation (EU MDR) and Risk Management — Reduce, Eliminate, Minimize, Remove or Avoid Risk?

Posted on 7 June 2021 (14 June 2021) by tim
Risk Management

Learn about the updated EU MDR’s strong emphasis on safety and risk management.

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Posted in medical device, regulations, risk management, UncategorizedTagged EU MDR, European Union, medical device, regulation, risk, risk management

Difference between Tollgate Reviews and Design Reviews

Posted on 17 May 2021 (17 May 2021) by tim
Tollgate Review vs Design Review

Tollgate Reviews and Design Reviews are both vital elements of product development, but many companies confuse the two. Here’s the difference.

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Posted in Design for six sigma, medical device

Integrating Medical Device Product Development, Design for Six Sigma and Quality Systems Requirements – Part 1

Posted on 17 April 2021 (17 April 2021) by tim
Implanted medical device

How to harmonize Quality System Requirements and DfSS with your New Product Development Process, Part 1…

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Posted in Design for six sigma, medical device, New Product Development, regulationsTagged Design for Six Sigma, New Product Development, Quality Systems Requirements

Integrating Medical Device Product Development, Design for Six Sigma and Quality Systems Requirements — Part 2

Posted on 17 April 2021 (17 April 2021) by tim
Medical Device

How to harmonize Quality System Requirements and DfSS with your New Product Development Process, Part 2…

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Posted in Design for six sigma, medical device, New Product Development, regulationsTagged Design for Six Sigma, New Product Development, Quality Systems Requirements

ISO 13485: The Global Quality Management Systems Standard for Medical Devices

Posted on 28 March 2021 (17 April 2021) by tim
ISO logo

With the explosion of medical devices and manufacturers, a need was realized to develop a medical-device-specific standard based on ISO 9001. The result is ISO 13485.

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Posted in medical device, regulationsTagged European Union, ISO 13485, medical devices, regulations

Medical Device Regulations Part 1 — USA

Posted on 18 January 2021 (17 April 2021) by tim
FDA Sign

Since 1906, the US FDA has sought to ensure the safety and efficacy of medical devices. This article outlines the history and rationale that created the Quality System Regulation for Medical Devices 21 CFR Parts 820.

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Posted in medical device, regulationsTagged 21 CFR part 820, FDA, GMP, medical devices, regulations, USA

Medical Device Regulations Part 2 — Europe

Posted on 18 January 2021 (17 April 2021) by tim
EU Medical Device Regulation

An introduction to The European Union Medical Device Regulation (EU MDR) 2017/745, CE certificates and the companion standard European Union Invitro Diagnostic Regulation (EU IVDR) 2017/746.

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Posted in medical device, regulationsTagged EU IVDR, EU MDR, European Union, medical devices, regulations

Brief History of Medical Devices and Regulations

Posted on 18 January 2021 (25 January 2021) by tim
Trepanation instruments, 18th century

Learn about that history of medical devices from ancient to modern times, and how regulations evolved in the mid-20th century to protect patients and ensure safe and effective medical devices.

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Posted in medical device, regulationsTagged history, medical devices, regulations
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Recent Posts

  • Focus on the Latest Regulatory and Risk Management Requirements for Medical Plastics
  • How to Reduce Risk As Far As Possible
  • European Union Medical Device Regulation (EU MDR) and Risk Management — Reduce, Eliminate, Minimize, Remove or Avoid Risk?
  • Difference between Tollgate Reviews and Design Reviews
  • Integrating Medical Device Product Development, Design for Six Sigma and Quality Systems Requirements – Part 1

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