Scott Stiles, Author at Quality Regulatory Specialists

How to Bundle Sterilization Process Changes for Multiple Medical Devices in a Single FDA Submission

Regulatory Compliance / By Scott Stiles / 3 minutes of reading / November 20, 2024

When managing regulatory submissions, efficiency is key—especially when it involves changes to the sterilization process for multiple medical devices. The FDA allows bundling of such changes into a single submission under certain conditions, helping manufacturers save time and resources. In this blog post, we’ll guide you through the essentials of bundling sterilization process changes effectively. […]

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Facing an FDA Inspection? Key Steps to Prevent a Warning Letter Before It’s Too Late

Regulatory Compliance / By Scott Stiles / 5 minutes of reading / November 13, 2024

When your business undergoes an FDA inspection, you’re on high alert to ensure everything complies with regulations. But even if you address some issues on the spot, receiving a Form 483 notice afterward can feel daunting. And beyond the Form 483, there’s a greater concern: a Warning Letter. An FDA Warning Letter escalates the severity

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Person Responsible for Regulatory Compliance (PRRC) under EU MDR/IVDR

Regulatory Compliance / By Scott Stiles / 7 minutes of reading / March 15, 2023

EU MDR (2017/745)1 and EU IVDR (2017/746)2, Article 15, both stipulate specific activities that must be carried out within a manufacturer’s organization by a person responsible for regulatory compliance (PRRC) who fulfills minimum conditions of qualification. In this post I will cover the following related to PRRCs: As we’ll see, the MDR requirements are fairly

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What are Common Specifications under EU MDR and IVDR?

Regulatory Compliance / By Scott Stiles / 7 minutes of reading / February 27, 2023

The quick answer to this question is a Common Specification (CS): “means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.”1 Essentially, the European Commission has reserved the right within both EU MDR1 and EU IVDR5

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What are harmonized standards under EU MDR and EU IVDR?

Regulatory Compliance / By Scott Stiles / 4 minutes of reading / February 7, 2023

The quick answer to this question is a harmonized standard (or “harmonised” standard in EU regulations), “means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonization legislation”1. While this sheds some light on the title question, in this post, I will answer in a

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Does EU MDR require on-site supplier audits?

Regulatory Compliance / By Scott Stiles / 5 minutes of reading / December 20, 2022

If your organization currently markets or plans to market medical devices within the EU, you may be wondering if EU MDR1 or EU IVDR2 requires on-site audits of your suppliers. EU MDR/EU IVDR does require notified bodies to consider the need for both announced and unannounced audits of your suppliers depending on risks associated with

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List of Mandatory Documents for ISO 13485 & FDA 21 CFR 820 Compliance

Quality Management System / By Scott Stiles / 3 minutes of reading / December 14, 2022

There is a long list of requirements, procedures, activities, or arrangements that you’re obliged to document to establish a quality management system that is compliant with ISO 13485 and FDA 21 CFR 820. For many of the requirements, the standard/regulation just requires them to be documented while for others the need for a documented procedure

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Quality Management System Procedures | Does verb choice matter?

Quality Management System / By Scott Stiles / 6 minutes of reading / December 6, 2022

In this post, we investigate the importance of verb choice within Quality Management System (QMS) procedures and work instructions. We will look at: All this and more to help you have a great result during your next audit or inspection! To get us started let’s look at what ISO 13485 has to say about the

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