Regulatory Compliance

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. […]

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

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

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

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

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

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

What are Common Specifications under EU MDR and IVDR? Read More »

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

What are harmonized standards under EU MDR and EU IVDR? Read More »

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

Does EU MDR require on-site supplier audits? Read More »

Call 949-288-1289
Call 949-288-1289
Scroll to Top