Regulatory for Medtech Companies

Medtech Regulatory Strategies Tailored for Your Success

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Global Medtech Regulatory Experts

Our medtech team delivers expert regulatory support, strategic insights, and operational services tailored to your needs in the EU, US, and beyond. Whether you’re navigating EU regulations, ensuring FDA compliance, or meeting local requirements in diverse markets, we’re your trusted partner in achieving global success with products such as medical devices, in vitro diagnostics, and software-based products.

Strategic and Operational Regulatory Support

Our Regulatory Medtech team offers strategic and operational services to streamline the device regulatory strategy in line with the regulatory authorities, client marketing claims, indications for use and business objectives.

Strategic Development Services

Our consulting services, based in both the EU and US, are designed to optimize your device’s regulatory strategy.

Gap Analysis

Customized report identifying the critical differences between the current state of the device development and where the company would like to be (i.e. product certification, Clinical Investigation Initiation, IVDR or MDR compliance, 21 CFR)
Recommendations on how to solve the gaps identified and next steps to be carried out
Recommendations on how to transit from one regulation/region to another

Regulatory Strategy

Customized report evaluating the regulatory requirements (e.g. MDR/IVDR/FDA) and tests needed according to the applicable standards
Define the potential development strategies and associated timing for each product, including pros, cons and risks associated

Due Diligence Assessment

Report identifying and assessing important regulatory issues of an asset
Conducted in multiple conditions and stages of development (e.g., FIH, prior to certification), both for licensing and for acquisition
Provide recommendations on potential regulatory implications and requirements and go / no-go decision from the regulatory perspective

Product Classification and Categorization

Determine main Mode of Action and product categorization (MD, IVD, Combination product, Drug, etc.)
Classify the device according to the EU MDR and IVDR and/or the US FDA guidelines
Review similar devices in the EU/US markets
Provide recommendations on product claims and intended use

Clinical Strategy

Collaborate with Medical Strategy, Biometrics and Clinical Operations divisions to design the synopsis and/or clinical trial protocol
Ensure the clinical strategy is in line with the regulatory requirements
Integrate reimbursement and go-to-market considerations in the trial design

EU Operational Services

Our Regulatory Medtech team offers services from an operational perspective supporting the procedures that need interaction with regulatory authorities in the EU and any other operational activity.

EU Technical Documentation Preparation

Technical Documentation (TD) preparation and/or review
Update TD with Post Market Requirements
Clinical evaluation/performance
Support and prepare Clinical Evaluation/Performance (CER and PER) documents
Advise and prepare Post Market Surveillance (PMS) strategy and documents including PMCF/PMPF
Risk Management
Unique Device Identifier (UDI) and EUDAMED

EU Notified Body (NB) and National Authorities

Selection of the notified body according to the type of device and client needs
Support and accompaniment during the evaluation and interactions with the NB
Interaction with EU Member State National Regulatory Authorities for consultation, clinical trial approval and others
Guidance on solving notified body on assessing non-conformities, review of CAPA plan, etc.

Audit Capacities

Online and onsite Internal Audits as per MDR/IVDR
Third-parties audits capacity of suppliers, distributors, developers, manufacturers, and other subcontractors
Assistance on assessing non- conformities

US Operational Services

Our Medtech team provides operational support services, facilitating interactions with regulatory authorities in the US and assisting with any other operational activities required.

FDA Meetings and Interactions

Prepare required documentation (writing, formatting, advice on content needed) and submit documents to the FDA
Lead and manage FDA meetings.
Type of meetings: Pre-Submission, 513(g) Request for Classification, Request for Designation (RFD),
Breakthrough Device Designation (BDD),
Safety Technologies Program (SteP),
Informational Meetings,
Submission Issue Requests (SIRs)

FDA Submissions including Documentation Preparation

Advise company on documentation needed
Prepare submission package and act as primary correspondent with the FDA
Lead and manage FDA meetings as part of the device submission
Submissions: 510(k), DeNovo, PMA (Pre-Market Approval), Investigational Device Exemption (IDE), Emergency Use Authorization (EUA), Humanitarian Device Exemption (HDE/HUD), CLIA, LDTs

Quality Management System Service

Our Regulatory Medtech team offers companies strategic services from the EU (ISO13485:2016), US QMSR (21CFR820), and combined regions (MDSAP) to enhance the quality management system for the development and manufacturing of any MD, IVD or Digital Health in line with the health authorities and business objectives.

QMS Gap Analysis

Customized analysis identifying the critical differences between the current QMS and the QMS under the ISO13485:2016, under the QMSR (21CFR820), or combined regions (e.g. MDSAP).
Recommendations on how to solve the gaps identified and next steps to be carried out.

QMS Implementation

Templates available for the implementation of the QMS following ISO13485:2016, the QMSR (21CFR820), or combined regions (e.g. MDSAP).
Support for the implementation of a system to follow quality standards in any stages of product development.

Training

ISO13485:2016 Medical Devices Quality Management Systems global or specific training.
ISO14971:2019 Risk Management training.
IEC62304:2006 Software Life Cycle Process training.
QMSR (21CFR820) global or specific training.
Ad-hoc trainings upon request.

Audit Capacities

Online and onsite Internal Audits, including MDSAP.
Third-parties audits capacity of suppliers, distributors, developers, manufacturers, and other subcontractors.
Assistance on assessing non- conformities, review CAPA plan, etc.

Additional Services

Our Regulatory Medtech team offers to companies a wide range of complementary services.

Other Regions and Country – Specific Requirements

Help companies transition to new frameworks for product registration in UK and Switzerland
Identify requirements and register medical devices in APAC, Canada, LATAM
Delineate best strategy to optimize resources & leverage data for product registry
Identify and provide to the client the country-specific requirements that should be fulfilled (i.e. Spanish prior-to-operate license)

Go-to-Market Strategy

Elaborate go-to-market strategy for any product in the EU, US and other regions
Full collaboration with Alira Health market access and strategic consulting practices to develop a complete and holistic strategies for market entry
Market overview considering regulatory and clinical, but also market access, price and reimbursement requirements

Training and Collaborations

Customized training services including specific on-site training activities for Medtech companies, investors groups, or pharma companies planning to develop MDs
Training tailored to client needs: type of product, regulatory requirements, etc.
Collaboration with Medtech and Regulatory clusters and associations
Global or specific training of IVDR (2017/746), MDR (2017/745), FDA
among others

Full Service Provider Model

Functional Service Provision (FSP): outsourced Regulatory team as part of client’s cross-functional team
Support design and execution of the company regulatory strategy
Support understanding of future regulatory needs
Coordinate different stakeholders involved in product’s development (toxicologist, clinicians, non-clinical experts…)

Why Choose Us for Your Medtech Regulatory Support?

We provide personalized services to meet each client’s needs/requests and adapt to each stage of development of the product.
Our extensive network of experts and key opinion leaders addresses specialized needs in numerous therapeutic areas.
We offer a holistic approach thanks to our integrated team, including biometrics, clinical, market access, strategic consulting, and patient engagement experts.

Webinar Replay

Developing an Effective Regulatory Strategy for the Evolving 2024 Medtech Landscape

How can you manage the crucial differences between the EU and US regulatory landscapes and the latest updates that could impact your business? Learn what you should consider when developing your regulatory strategies and how to prioritize target markets amidst these shifting regulations in this on-demand webinar.

Our Experience

Our consultants have experience with different regulatory procedures for different types of devices across a wide range of therapeutic areas — including over 200 medical device certifications in the US FDA and EU, and over 100 interactions with the FDA and notified bodies.

At Alira Health we provide EU and US strategic and operational regulatory support for medical devices, IVDs, combination products, companion diagnostics, digital health, and more. We have a track record of over one hundred NBs/FDA direct interaction submission experience and we cover a wide range of therapeutic areas."

~ Ainoa Forteza
Vice President, Regulatory Affairs