Regulatory Affairs

Implantable medical devices ›

Implantable medical devices, remaining in the human body for a long-term period, must meet strict requirements under the Medical Device Regulation (MDR) 2017/745 to ensure they are safe and effective for patients. Consequently, these devices are subject to more stringent provisions compared to other types of medical devices under the MDR.

Annex XVI products ›

MDR Annex XVI products refer to products that have no intended medical purpose. Before the MDR was implemented, these products often fell into a regulatory “gray area.” Due to the potential high risks they pose to users, these products are now governed by the strict regulations of the MDR.

Drug-device combination products ›

In the ever-evolving medical field, the combination of medical devices with medicinal products presents unique challenges and opportunities. Such products, whether used together in various configurations or as single integral products, must comply with stringent regulatory frameworks to ensure patient safety and product efficacy.

Medical devices that incorporate ancillary substances ›

For companies developing medical devices, understanding the relevant regulatory framework is crucial. The Medical Device Regulation (EU) 2017/745 (MDR) requires a clear distinction between medical devices and medicinal products, as this classification affects the compliance process and regulatory requirements.

Regulatory Affairs Training ›

In a highly regulated industry, staying up-to-date with ever-evolving regulatory requirements is crucial for ensuring compliance, market access, and the safety and efficacy of products. Regulatory affairs professionals play a vital role in navigating these complex regulations and standards, such as ISO 13485, MDR 2017/745, and FDA requirements. Understanding the fundamentals of these rules is not an easy task.

Gap Analysis for MDR 2017/745 ›

The Medical Device Regulation (MDR) 2017/745 represents a significant overhaul of the regulatory framework governing medical devices in the European Union. This regulation aims to ensure a high level of safety and performance for medical devices to be available within the union, incorporating stricter requirements for clinical evidence, post-market surveillance, and traceability. For manufacturers, transitioning from the previous Medical Device Directive (MDD) to MDR poses numerous challenges, including understanding the new requirements, identifying gaps in compliance, and implementing necessary changes.

Product Qualification ›

Product qualification is a critical service for manufacturers navigating the complex regulatory landscape.

Medical Device Technical Documentation ›

Technical documentation is the summary of the product development work that has been completed. How you write this document gives a clear understanding of how you comply with the requirements of medical devices. It provides comprehensive information about the device’s design, development, testing, and performance, ensuring that it meets regulatory standards and demonstrates safety and efficacy.

Medical Device Classification ›

Medical device classification is a critical initial step in developing your product. The classification will impact all the other design choices-therefore it is very crucial to get it right from the get-go. Engineering work of a high-risk product is a completely different ballgame than a low-risk product.

Regulatory Support for Your Medical Device

Navigating the regulations for medical devices can be challenging. The regulatory environment is diverse and includes regulations, standards, guidelines, and more. The applicability of these requirements depends on various factors, such as the target market, the type of medical device, and its risk classification.

Adhering to these regulations is essential for bringing medical devices to market. The scrutiny doesn’t stop once a product is launched – it continues throughout its lifecycle and even after it’s removed from the market.

Given this complexity, manufacturers often need additional knowledge and expertise. We’re here to provide our support, offering various resources to assist you in effectively addressing these regulatory challenges.

What can we do for you?

Gap analysis (MDR 2017/745)
Post-market surveillance
Regulatory strategy
Regulatory support (EU (EMA) and US (FDA))
Regulatory affairs training
Medical device classification
Medical device development support
Drug-device combination products
SaMD
Medical device technical documentation (writing, gap analysis)
IVDR
Communication with NB/CA

Management team member - Senior RA Manager

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