CQURA

Supporting a Top-5 US-based Digital Health Client with MDR Submission for Class IIa SaMD

Client Overview

A global top 5 digital health company developing a Class IIa Software as a Medical Device (SaMD). 

Challenge

The client needed to compile comprehensive MDR-compliant technical documentation for their SaMD product, targeting a submission to a Notified Body under the EU Medical Device Regulation (MDR). 

CQURA’s Approach

•  Worked closely with the client’s regulatory, clinical, and engineering teams, liaising on a day-to-day basis to ensure alignment and real-time progress.

• Assisted in drafting and justifying the regulatory classification of the software under MDR, providing strategic input to support the submission.

• Collaborated with client to draft key MDR documents including,  Summary Technical File, Device Description, Clinical Evaluation, Post-Market Surveillance (PMS) Plan

•  Reviewed and provided detailed feedback on risk management, labelling and Instructions for Use (IFU) to ensure full compliance with MDR Annex II and III.

• Ensured all documents met regulatory expectations while accurately reflecting the client's product design, intended use, and risk profile.

Outcome

• The client successfully submitted the MDR technical documentation, which was accepted by the Notified Body with no major deficiencies, enabling timely market access.

• CQURA continues to support the client in updating their technical file for surveillance audits and ongoing compliance under MDR.​

Regulatory Assessment Support for SaMD and IVD UK and EU-based Start-ups

Client Overview

Multiple early-stage companies developing Software as a Medical Device (SaMD) and In Vitro Diagnostics (IVDs)seeking to understand regulatory pathways in the UK and EU markets.

Challenge

Start-ups needed expert guidance to determine the regulatory classification and requirements for their devices under UK MDR 2002 (as amended), EU MDR 2017/745, and EU IVDR 2017/746 while ensuring marketing claims and intended purpose were compliant.

CQURA’s Approach

• Engaged in collaborative demo sessions to fully understand each device’s functionality and intended use.

• Reviewed client claims, websites, and promotional materials to identify potential compliance gaps.

• Performed detailed regulatory assessments across applicable UK and EU regulations.

• Delivered written reports with clear classification rationale and regulatory obligations.

• Provided MDR overview training and when requested, tailored intended purpose and regulatory assessment templates for client use.

Outcome

• Clients successfully refined intended purpose statements and updated or removed non-compliant claims.

• Gained a clear understanding of their regulatory pathway and compliance obligations.

• CQURA continues to provide ad-hoc regulatory advisory support to the client(s) as they advance product development.

510(k) Submission Support for Top 5 US-based Digital Health Company

Client Overview

A global top 5 digital health company developing Class II Software as a Medical Device (SaMD), seeking regulatory clearance for entry into the U.S. market.

Challenge

The client required support to determine the regulatory classification, 513g application to the FDA for a new device, followed by preparation and submission of a 510(k) application.

CQURA’s Approach

• Supported the client in preparing and submitting a 513(g) application to the FDA, helping to clarify the device’s classification, clinical evidence requirements and applicable regulatory requirements.

• Following a successful 513(g) outcome, worked collaboratively with client teams on a daily basis to develop the eSTAR documentation package for 510(k) submission.

• Assisted in drafting and reviewing key documents for submission, ensuring accuracy and alignment with FDA expectations.

• Provided support in responding to FDA queries during the Additional Information (AI) request phase, helping to address all issues efficiently.

Outcome

• The client successfully obtained 510(k) clearance with no further AI requests from the FDA.

• CQURA continues to support the client with upcoming FDA submissions for new medical devices.

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Clinical Function Setup and MDR Remediation for Medical Device Manufacturer

Client Overview

A UK/EU-based medical device manufacturer transitioning its clinical documentation and processes from MDD to MDR requirements.

Challenge

The client required support to establish a robust clinical function, remediate legacy clinical documentation, develop compliant procedures and templates, and prepare for successful regulatory audits under EU MDR 2017/745.

CQURA’s Approach

CQURA supported the client in establishing and strengthening its clinical research and clinical evaluation function, including:

• Developing clinical evaluation procedures, processes, templates and governance frameworks.

• Supporting remediation of clinical documentation from MDD to MDR requirements.

• Advising on clinical evaluation strategy, clinical evidence requirements and documentation expectations.

• Supporting audit readiness through document reviews, gap assessments and preparation of responses to potential auditor queries.

• Providing training to internal teams on MDR clinical evaluation expectations and lifecycle responsibilities.

• Advising on team structure, hiring needs and ongoing clinical research function development.

Outcome

• The client strengthened its internal clinical function, improved MDR readiness and successfully progressed through audit activities. CQURA continues to support the client with clinical research, clinical evaluation and ongoing clinical function development.

Biocompatibility Procedure, Training and Documentation Support

Client Overview

Medical device manufacturer requiring support with biological safety evaluation documentation and internal process development.

Challenge

The client needed to align their biocompatibility processes and documentation with ISO 10993 and US FDA expectations, while ensuring internal teams understood study planning and documentation requirements.

CQURA’s Approach

• Developing procedures and templates aligned with ISO 10993 and FDA biocompatibility expectations.

• Preparing training materials for internal teams.

• Authoring Biological Evaluation Plans and Biological Evaluation Reports.

• Advising on biological safety risk assessment and study planning.

• Supporting responses to client and technical queries relating to biocompatibility documentation.

Outcome

• The client established clearer biocompatibility documentation processes, improved internal understanding of ISO 10993/FDA expectations and strengthened biological safety documentation for regulatory submissions and technical files.​​​​

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Lecture, Training and Module Development
 

Client Overview

Academic institutions, professional bodies and life sciences organisations seeking regulatory, patient safety and MedTech training support.

Challenge

Clients required expert input to develop and deliver high-quality educational content on medical device regulation, patient safety, clinical evidence and regulatory strategy for academic, professional and industry audiences.

CQURA’s Approach

• Supported proposal development for a university grant application.

• Developed training materials, lectures and modular educational content on medical device regulation, clinical evidence and patient safety.

• Delivered a TOPRA webinar for regulatory affairs professionals.

• Delivered an invited talk for a Top 5 combination product client on clinical evaluation requirements and the European Commission’s COMBINE initiative.

• Delivered an annual regulatory lecture at University College London.

• Helped content delivery for patient safety module at King’s College London.

• Tailored content for academic, professional and industry audiences, using practical regulatory examples and case studies.

Outcome

• Supported knowledge transfer across academic, professional and industry settings.

• Helped participants strengthen understanding of regulatory strategy, clinical evidence, patient safety and medical device development.

• Contributed expert MedTech regulatory input to university-level teaching, professional education and grant development activities.​​​

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MDR Transition Support for UK-based Mid-Size Medical Device Manufacturer

Client Overview

A mid-sized medical device manufacturer with a Class I to Class IIb portfolio, transitioning from MDD 93/42/EEC to MDR 2017/745.

Challenge

The client needed support to update Technical Files and QMS procedures to meet MDR requirements and prepare for regulatory audits.

CQURA’s Approach

• Worked collaboratively with client teams, liaising daily across regulatory and quality functions.

• Delivered tailored MDR training to upskill internal teams. Training included an overview of MDR requirements, clinical evaluation, usability, ISO 13485 quality management system, and biocompatibility requirements. 

• Supported QMS updates, including creation of MDR-compliant procedures, templates and training on specific processes.

• Helped update Technical File elements: intended purpose, device description, risk management, clinical evaluation, biocompatibility, PMS, and PMCF plans.

• Supported the client in preparing for Stage 1 QMS audit, including document reviews and readiness assessments.

• Provided direct support during the audit, addressing auditor queries in real-time and ensuring smooth audit execution.

Outcome

• The client established new processes under the updated QMS procedures, successfully completed the Stage 1 QMS audit with no major deficiencies and is currently preparing for the Stage 2 audit.

• CQURA continues to support the client in finalising preparations for the Stage 2 MDR audit. ​

EU Battery Regulation Compliance for EU-based Class III Medical Device Manufacturer

Client Overview

A manufacturer of Class III and critical medical devices seeking compliance with the EU Battery Regulation (EU 2023/1542) due to battery-powered components in their devices.

Challenge

The client required support to meet the first transition deadline of 18 August 2024, ensuring updates to their QMS procedures and economic operator agreements, and to understand obligations under the new regulation.

CQURA’s Approach

• Worked with the client team to review the gap analysis, existing QMS SOPs, and economic operator agreements.

• Supported the update of procedures and agreements to align with Battery Regulation requirements.

• Helped review labelling and Instructions for Use (IFU) to ensure compliance with new obligations.

• Drafted internal memos and external communications to align messaging across the organisation and with external stakeholders.

• Supported in delivering targeted training to in-country managers, clarifying roles and obligations under the regulation.

Outcome

• The client completed all updates ahead of the first transition deadline (18 August 2024).

• The client has an economic operator framework to meet the obligations for batteries for medical devices in development. 

• CQURA continues to work with the client to prepare for the next phase, focusing on producer and due diligence requirements. 

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Special 510(k) Submission Support for Top 5 US-based Digital Health Company

Client Overview

A global top 5 digital health company introducing modifications to an existing Class II Software as a Medical Device (SaMD), requiring submission of a Special 510(k) to the FDA.

Challenge

The client needed expert support to prepare a Special 510(k) submission, ensuring that modifications to their cleared device met FDA requirements and could leverage an expedited review pathway.

CQURA’s Approach

• Collaborated closely with the client’s regulatory and engineering teams, with day-to-day engagement to understand the scope of device modifications.

• Reviewed change rationale, risk assessment, and verification/validation data to ensure eligibility for the Special 510(k) route.

• Supported drafting and review of the Special 510(k) documentation package using the FDA’s eSTAR template.

• Advised on and helped finalise key elements, including device description updates, a summary of changes, and test reports.

• Provided guidance during FDA interactions, helping the client respond to clarification requests efficiently.

Outcome

• The client successfully obtained Special 510(k) clearance within the expected shortened review timeframe, with no additional information requests from the FDA.

• CQURAcontinues to support the client with regulatory change assessments under EU MDR, ensuring ongoing compliance for the modified device in the European market.

Human Factors and Usability Engineering Support for Medical Device, SaMD and IVD Clients

Client Overview

Medical Device, SaMD, IVD and AI-based medical device manufacturers seeking support with human factors, usability engineering and design control requirements.

Challenge

Clients needed to understand how to embed usability engineering into product development, including additional considerations for AI-based devices such as user understanding of algorithm outputs, automation bias, human oversight, explainability, alerts, workflow integration and foreseeable misuse.

CQURA’s Approach

• Performed human factors and usability engineering gap assessments for SaMD, IVD and AI-based medical devices.

• Reviewed usability documentation against IEC 62366 expectations.

• Advised on integrating usability activities into design and development processes.

• Delivered targeted training on human factors requirements for SaMD, IVD and AI-based devices.

• Highlighted additional human factor considerations for AI-enabled workflows, including user interaction with algorithm outputs, human oversight, automation bias, explainability, risk controls, labelling, training and design validation.

Outcome

• Clients improved their understanding of usability engineering requirements and strengthened their design control processes for software, IVD and AI-based devices, reducing the risk of late-stage documentation gaps, usability-related deficiencies and costly rework.

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Regulatory Intelligence Support for Class, IIa, IIb, III Medical Device Manufacturer(s)

Client Overview

Medical device manufacturers of Class IIa, Class IIb and III requiring ongoing regulatory intelligence support across the EU, UK and Switzerland.

Challenge

The client needed continuous monitoring of regulatory developments across key markets and support assessing whether new or updated requirements could impact their products, procedures, processes or quality management system.

CQURA’s Approach

• Conducted ongoing regulatory intelligence assessments across EU, UK and Swiss regulatory databases and official sources.

• Monitored changes to regulations, guidance, standards and competent authority expectations relevant to Class III medical devices.

• Performed impact assessments to determine applicability and potential implications for products, procedures, processes and QMS documentation.

• Liaised with regulatory, quality, clinical and technical teams to assess operational impact and agree required actions.

• Provided clear summaries and action-oriented outputs to support internal decision-making and compliance planning.

Outcome

• The client maintained ongoing visibility of relevant EU, UK and Swiss regulatory changes.

• CQURA continues to support the client with ongoing regulatory intelligence monitoring and impact assessment.​

Regulator, Notified Body, Submission and Audit Support

Client Overview

Multiple medical device, SaMD and IVD manufacturers preparing for regulatory submissions, CE marking, QMS certification, FDA engagement and competent authority interactions.

Challenge

Clients required support with Notified Body selection, submission preparation, audit readiness, regulator communications, FDA 513(g) requests, clinical study competent authority responses, technical queries and non-conformity responses.

CQURA’s Approach

• Advised on Notified Body and regulator engagement strategy.

• Conducted internal audits and readiness assessments against QMS, ISO 13485, MDR/IVDR and applicable regulatory requirements.

• Supported audit planning, agenda preparation, evidence collation and preparation of client teams.

• Provided front room audit support, including auditor interaction management, SME coordination, request tracking and real-time response support.

• Supported FDA 513(g) classification requests for medical device and SaMD products.

• Supported responses to competent authority queries for clinical studies.

• Assisted with responses to technical queries, audit findings and non-conformities.

Outcome

• Clients improved submission, inspection and audit readiness across QMS, technical documentation and regulatory processes.

• Internal audits helped identify and resolve gaps before Notified Body, Approved Body or regulator review.

• Front room audit support enabled clients to manage auditor interactions, coordinate evidence requests and respond to queries efficiently.

• Clients progressed more effectively through regulatory submissions, audits, competent authority interactions and non-conformity responses.​