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

Regulatory Compliance / By / 3 minutes of reading /

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 / 5 minutes of reading /

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 / 7 minutes of reading /

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 / 7 minutes of reading /

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 / 4 minutes of reading /

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 / 5 minutes of reading /

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 / 3 minutes of reading /

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 / 6 minutes of reading /

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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