Posts by Taimoor Khan

May 1

Taimoor Khan in Eastern Region, Quality, Regulatory | No comments

FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions

The FDA recently (April, 2023) came out with a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The document provides guidance for developing a Predetermined Change Control Plan (PCCP) for managing changes to the device software functions. The PCCP is a critical component of […]

Jan 1

Taimoor Khan in Eastern Region, Quality, Regulatory | No comments

FDA Action Plan for AI/ML in SaMD (Software as a Medical Device)

Artificial intelligence (AI) and machine learning (ML) technologies have a huge potential to change the way we look at our current health care practices. AI/ML enable new insights derived from the huge amount of data that is collected every day in the health care sector. This blog provides an overview of the FDA action plan […]

Sep 3

Taimoor Khan in Business, Quality, Regulatory | No comments

Cleanroom Validation Testing for Medical Device Manufacturing

This blog provides an overview of Medical Device Manufacturing Cleanrooms and draws upon our experience validating our Class 7 Cleanroom. A highly regulated environment, like that of a ISO 13485:2016 certified medical device manufacturer, requires assurance that critical processes can be performed within a controlled environment.

Dec 1

Taimoor Khan in Manufacturing, Regulatory | 4 comments

Qualifying and Managing RoHS and REACH suppliers

Companies manufacturing equipment or consumer parts that use hazardous materials in the manufacturing process must comply with RoHS and REACH environment regulations. RoHS and REACH are two regulations that require compliance if a company intends to sell in the European Union, China, Korea and some parts of the United States and Canada. Therefore it is […]

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Posts by Taimoor Khan

FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions

FDA Action Plan for AI/ML in SaMD (Software as a Medical Device)

Cleanroom Validation Testing for Medical Device Manufacturing

Qualifying and Managing RoHS and REACH suppliers

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