Regulatory Consulting
Service Overview
At Iberania, we provide expert regulatory consulting services to guide your medical device product through the regulatory landscape. With our in-depth knowledge of local and international regulations, we help you navigate the requirements for market approval, from initial product development to post-market surveillance. Our team offers tailored solutions to ensure compliance, mitigate risks, and accelerate your path to market, while maintaining the highest standards of quality.
Technical documentation
Iberania provides support in preparing and developing the Technical Documentation of your medical device to meet the regulatory requirements, ensuring your product complies with all necessary standards.
Our team helps you to organize, develop, and complete the required documents and sections including:
Device description and specification
Product label
Instructions for Use (IFU)
Design and manufacturing information
General Safety and Performance Requirements (GSPR)
Benefit-risk analysis
Product verification and validation
Regulatory Strategy
Our Regulatory Strategy team guides you through the entire regulatory pathway, from initial product concept to market. We develop customized strategies tailored to your product, ensuring an efficient and compliant route to market.
As part of these services, we offer CE-Mark Roadmap. CE-Mark Roadmap is a strategic plan that outlines the entire process for obtaining CE mark for a medical device in Europe. It acts as a step-by-step guide, starting from the early stages of product development and continuing through to the final regulatory approval. This roadmap helps you understand the necessary requirements, timelines, and regulatory milestones to achieve compliance with the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).
Product Equivalence
Product Equivalence evaluates whether your medical device is comparable to existing products on the market, predicate or equivalent devices. The equivalence analysis is essential for determining the necessary clinical evidence required for your medical device approval, and plays a key role in reducing both costs and time.
Literature Search
The Literature Search consists of a systematic review of existing scientific and clinical literature to support the safety and performance claims of your medical device. This is crucial for regulatory submissions and ensuring that your product meets all necessary clinical evidence requirements.
Post-Market Surveillance
Post-Market Surveillance means the ongoing monitoring of your product’s safety and performance once the medical device reaches the market. We support manufacturers in developing and implementing PMS Plans to monitor device performance, identify risks, and comply with regulatory requirements.
Our experts also assist in preparing Periodic Safety Update Reports (PSUR) for higher-class devices and PMS Reports for Class I devices, ensuring timely and accurate documentation of post-market data. Additionally, as part of the post-market surveillance, we develop and execute Post-Market Clinical Follow-Up (PMCF) Plans to gather real-world clinical evidence.
Clinical Evaluation
Our experts assist you in developing a detailed Clinical Evaluation Plan (CEP), which outlines the strategy for gathering and analyzing clinical data throughout the device's lifecycle.
In addition, we will support you in the development of the Clinical Evaluation Report (CER) where the data is compiled, demonstrating compliance with regulatory standards such as the EU MDR.
Summary of Safety and Clinical Performance (SSCP)
Iberania assists in developing the Summary of Safety and Clinical Performance (SSCP) for your device, as required for all class III and class IIb implantable devices under the EU MDR. We guide you through the preparation of the SSCP or develop it for you, ensuring that all required clinical evidence and safety data are included.
Risk Management
Iberania provides support in the identification, assessment, and evaluation of your product risks. We work closely with you to propose strategies to mitigate risks. The service includes the development of Risk Management Plan and Risk Management Report ensuring compliance with ISO 14971 and minimizing potential hazards.