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Medical Devices

Supporting your product lifecycle

 

We help you in your journey from concept to commercialization

 

The Clinical Academic Center of Braga (2CA-Braga) understands that bringing a product to the market can be challenging.

Successfully ensure all phases of product development, from conceptualization to marketing, means a commitment to patient safety and is crucial for the company’s sustained success within the healthcare industry. 

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Knowledge and expertise

Knowledge and expertise for launching your medical device successfully

Our consultants offer extensive knowledge and expertise to support your company from beginning.

 

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Feasibility Analysis Services

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Software Development Services

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Regulatory Services

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Market Access Services

Feasibility Analysis Services

Assessment of Conceptual Feasibility and Business Viability

We conduct detailed analyses to determine the conceptual feasibility of your solution, as well as evaluate your business and financial models.

In addition, we generate compelling evidence of the economic impact of implementing innovative clinical solutions, ensuring their feasibility and potential for market success.

Economic Impact Assessment

Generating compelling evidence on the economic impact of implementing innovative clinical solutions

Business and Financial Model

Evaluating business and financial models to ensure the solution's feasibility and its potential for market success

Conceptual Feasibility Analysis

Conducting detailed analyses to ensure the feasibility of your solution, ensuring it meets all necessary requirements and standards

Market Feasibility

Conducting a comprehensive study of market conditions to assess the potential success and acceptance of innovative clinical solutions

Software Development Services

Support on validation and development of the software

Providing support in validating the components, architecture, and structure of the solution in alignment with best practices, from the development phase (functional, integrated, automated, and scalability testing).

Validation in compliance with cybersecurity standards, GDPR and other relevant data protection regulations

Solution Architecture

Validation of components, architecture, and structure in accordance with best practices

Solution Development Support

Assistance during the development phase with functional, integrated, automated, and scalability testing

Cybersecurity and Data Protection

Ensuring compliance with cybersecurity standards, GDPR, and other relevant data protection regulations

Optimization and Performance

Enhancing the efficiency and performance of the solution through rigorous testing and validation processes

Regulatory Services

Regulatory Process Support

Regulatory strategy and support throughout the entire lifecycle of the medical device, including Quality System management, gap analysis, and communication with the Notified Body.

 

Regulatory Strategy and Support

Develop and implement a tailored regulatory strategy to ensure compliance throughout the entire product lifecycle

Quality Management System

Develop and maintain a robust Quality Management System to ensure consistent product quality and regulatory compliance

Communication with the Notified Body

Facilitate and promote ongoing communication with the Notified Body to ensure efficient regulatory approval processes

GAP Analysis

Perform gap analysis to identify and address compliance shortcomings in systems and documentation

Marketing and Promotion

Support for marketing and promotional activities

Development and execution of targeted marketing and promotional campaigns tailored to effectively reach the target audience.

Creation of a commercialization model outlining strategic approaches and revenue streams.

Formation of strategic partnerships to expand market reach and drive business growth.

Market Research and Target Analysis

Conducting market research to identify target audience segments and understand their preferences and behaviors

Campaign Design and Execution

Developing and executing personalised marketing and promotional campaigns to attract the identified target audience

Commercialization Strategy Development

Creating a commercialization model detailing strategic approaches and potential revenue streams for optimal market penetration

Strategic Partnership

Building strategic partnerships to expand market reach, enhance brand visibility, and drive business growth

We can help

Whether you need occasional assistance with product strategies or a dedicated team to manage all your commercialization needs, we are here to support you

Our expertise extends across all clinical specialities, providing the leadership and knowledge necessary to bring your safe and effective products to market.

 

Contact Us

Please reach out to us, and we will respond at the earliest opportunity.