Plan in Line with Business Goals
CREATE with Expertise
Succeed with Confidence
Efficient Organisational Planning: Prioritising Within Business Needs
In the dynamic landscape of business, effective planning is crucial for success. Our consultancy specializes in organising planning strategies that revolve around your unique business needs. By setting clear priorities and aligning them with your broader objectives, we empower your organization to navigate challenges, seize opportunities, and achieve optimal outcomes.
Services
EU-Medical Device Regulation
Bringing years of expertise, our EU-MDR consultancy excels in creating MDR-compliant technical files from scratch, ensuring strict adherence to the regulations of the European Union Medical Device Regulation. Rely on us to adeptly navigate complexities, enabling your medical devices to enter the European market confidently.
US-FDA| 510(k) and PMA submission
Bringing years of expertise, our consultancy specializes in crafting 510(k) and PMA submissions for the US FDA. Our adept team ensures meticulous preparation, guiding your medical devices through the intricate pathways of FDA regulations. Count on us for successful market entry in the United States.
Health Canada-Medical Device Application
Leveraging our extensive expertise, our consultancy specialises in crafting Medical Device License Applications for Health Canada.
Our capable team ensures meticulous preparation, guiding your devices through the intricacies of Canadian regulatory requirements.
EU-In Vitro Diagnostics Regulation
With a wealth of experience, our consultancy excels in composing performance evaluation reports in alignment with the EU-IVDR.
Our adept team ensures meticulous preparation, guiding your In Vitro Diagnostic Devices through the complexities of European regulatory requirements.
Strategic Regulatory Alignment: Integrating Compliance with Business Objectives
We collaborate closely with companies to align regulatory strategies with overall business goals. Our experts ensure that regulatory efforts are integrated seamlessly into your organisations broader strategy.
Expertise
Technical Documentation Drafting
Our expert team specialises in creating these files, ensuring strict adherence to regulations like EU MDR, IVDR, and FDA requirements.
Literature Review & Appraisal
Our consultancy excels in evaluating and appraising relevant scientific literature, providing essential evidence on the state of the art of treatment.
Clinical evaluation
Our proficiency extends to drafting clinical evaluations to substantiate sufficient clinical evidence, or if additional clinical evidence is required.
Performance Evaluation
Our expertise covers support for creation of performance evaluations that encompass analytical, scientific, and clinical dimensions. We meticulously compile data, ensuring the coherent integration of each section.
Preparation of FDA Submission
We will compile and refine the finalised FDA submission in Electronic Common Technical Document (eCTD) format, to meet the exacting standards set by the FDA.
Medical Device License- Canada
By preparing a MDL application for Canada and drafting summaries, manufacturers can significantly improve their chances of successfully approvals for their devices.
Latest Article & Blog
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MDR – language requirements for manufacturers (January 2024).xlsx
Excel document containing the language requirements for manufacturers under the Medical Device Regulation (MDR)-January 2024.