Start Up Consultancy

Medical Device Consultancy for Start-Ups

Unlock Innovation, Accelerate Time-to-Market

At QReg, we specialize in guiding start-ups through the complex journey of medical device product development. Our tailored solutions are designed to help you bring groundbreaking medical devices from concept to market with efficiency, compliance, and confidence. Whether you’re a new entrant in the medical device industry or a tech innovator exploring healthcare solutions, our expert team is here to support you at every stage of development.

Our Comprehensive Services Include:

1. Concept Development and Feasibility Analysis

Idea Refinement:Collaborate with our experts to refine your concept, ensuring it addresses a genuine market need and is technically feasible.

Market Research:Gain insights into market trends, competitor analysis, and potential user feedback to validate your product idea.

Feasibility Studies:Assess technical and commercial viability through detailed feasibility studies, including proof-of-concept prototypes.

2. Regulatory Strategy and Compliance

Regulatory Pathway:Develop a clear regulatory strategy tailored to your specific device and target markets.

Quality Assurance:Implement rigorous quality assurance processes to meet international standards (ISO 13485).

FDA, UKCA and CE Marking:Navigate the complexities of FDA approval, UKCA and CE marking processes with our regulatory experts.

Documentation Support:Ensure all necessary documentation is prepared and maintained in compliance with regulatory standards.

3. Design and Development

Product Design:Leverage our design expertise to create ergonomic, user-friendly, and clinically effective medical devices.

Engineering Services:Utilize advanced engineering capabilities for robust product development, including hardware and software integration.

Prototyping:Rapidly develop and iterate prototypes to test functionality, usability, and manufacturability.

4. Testing and Validation

Preclinical Testing:Conduct comprehensive preclinical testing to ensure safety and efficacy.

Clinical Trials:Design and manage clinical trials to gather essential data for regulatory submissions.

5. Certification Assistance

Notified Body:We will assist you in finding Notified Body for your certifications and help you get through the notified body assessments.

Authorized Representative:Appoint one of our entities or trusted partners as regional Authorized Representative and registration holder.

6. Manufacturing and Scale-Up

Pilot Production:Transition from prototype to pilot production with seamless scaling capabilities.

Supplier Management:Source reliable suppliers and manage the supply chain for consistent quality.

Cost Optimization:Optimize production processes to reduce costs without compromising quality.

Contract Manufacturing: Optimize production processes to reduce costs without compromising quality.

7. Market Launch and Post-Market Surveillance

Go-to-Market Strategy: Develop and execute a strategic plan for a successful product launch.

Marketing and Sales Support: Equip your team with the necessary tools and training for effective market penetration.

Digital Marketing: Our specialized digital marketing services for medical device manufacturers are designed to help you navigate the complex landscape, ensuring your products reach the right audience with precision and impact.

Distributor Recruitment: Tailored service to connect you with top-tier distributors who specialize in medical devices

Post-Market Monitoring: Continuously monitor product performance and gather user feedback to inform future iterations.

Why Choose Us?

Expertise: Our team comprises industry veterans with extensive experience in medical device development.

Innovation: We foster a culture of innovation, helping you bring unique solutions to market.

Agility: Our agile development approach ensures flexibility and responsiveness to changing requirements.

Compliance: We prioritize regulatory compliance, ensuring your product meets all necessary standards.

Partner with QReg

Embark on your medical device development journey with a trusted partner committed to your success. QReg provides end-to-end support, transforming your innovative ideas into market-ready products that can improve patient outcomes and drive your start-up’s growth.