CQURA

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.​

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.

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.

​​​

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. ​

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. 

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.

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