Product development consulting and medical device design services
Our team of experts provides efficient and cost-effective solutions for your projects.
About RDEC
Our Company
RDEC is a premier consulting firm specializing in engineering and product development services for medical devices, combination products, and industrial systems. Our team of highly experienced professionals brings a wealth of knowledge in engineering, regulatory compliance, product development, and project management, making us a valuable partner for companies looking to bring their innovative ideas to life. Whether at the early stages of product development or further along the process, we are here to help navigate challenges and deliver exceptional results.
Our Approach
At RDEC, we pride ourselves on tailoring our services to the unique needs of each client. We believe that every project is an opportunity to innovate, and we approach every challenge with creativity and precision. By combining technical expertise with a deep understanding of industry regulations, we ensure our clients' products meet the highest standards of quality, safety, and compliance. From concept to commercialization, our commitment to excellence ensures your project’s success at every stage.
Our Values
- Innovation: We embrace cutting-edge solutions to create groundbreaking products and processes.
- Collaboration: We work closely with our clients to understand their needs and achieve their goals.
- Reliability: We deliver consistent, high-quality results you can trust.
- Integrity: We are committed to ethical practices and maintaining the highest standards of professionalism.
Benefits of Choosing RDEC
When you choose RDEC, you gain access to:
- End-to-End Expertise: We support your product development journey at any stage, whether it’s conceptualization, prototyping, or commercialization.
- Customized Solutions: Our services are tailored to your specific needs, ensuring innovative and practical outcomes that align with your goals.
- Regulatory Knowledge: With a deep understanding of FDA and international regulations, we help you navigate the complexities of compliance with confidence.
- Comprehensive Support: From engineering design to quality assurance, project management, and packaging design, we provide a seamless and integrated approach.
- Faster Time-to-Market: Our efficient processes and technical know-how streamline development, helping you launch your products on time and within budget.
By choosing RDEC, you’re not just hiring a consultant—you’re partnering with a team that is dedicated to your success and equipped to handle the most complex challenges.
Services
Medical Device Design & Development
Medical Device Design & Development
Medical Device Design & Development
RDEC provides expert consulting services to support the design and development of medical devices across all classes. Our expertise spans every stage of the development process, ensuring your product is ready for market.
Mechanical Engineering
Medical Device Design & Development
Medical Device Design & Development
RDEC provides advanced mechanical engineering services to support the design, analysis, and prototyping of high-performing mechanical systems. Our expertise spans from simple components to complex electromechanical mechanisms, ensuring innovative and reliable solutions tailored to your needs.
Packaging Design & Development
Packaging Design & Development
Packaging Design & Development
RDEC offers specialized packaging design services for medical devices and consumables, ensuring safety, compliance, and efficiency throughout the product lifecycle. From concept to commercialization, our solutions address all levels of packaging needs and regulatory requirements.
INDUSTRIAL ENGINEERING
Packaging Design & Development
Packaging Design & Development
RDEC supports process optimization and system integration for industrial engineering projects, helping clients streamline manufacturing processes and improve operational efficiency. Our services ensure seamless transitions from design to production, addressing challenges at every stage.
QUALITY ASSURANCE (QA) ASSISTANCE
QUALITY ASSURANCE (QA) ASSISTANCE
QUALITY ASSURANCE (QA) ASSISTANCE
RDEC helps you establish and maintain a robust quality management system (QMS) to meet the latest FDA regulations and international standards. Whether setting up a new QMS or optimizing an existing one, our experts ensure compliance and operational excellence.
Non-Clinical Assistance
QUALITY ASSURANCE (QA) ASSISTANCE
QUALITY ASSURANCE (QA) ASSISTANCE
RDEC provides expert support for non-clinical studies, helping ensure your medical devices and combination products meet safety and performance requirements. We collaborate with clients to streamline the non-clinical testing process and coordinate with testing providers to ensure successful outcomes.
Human Factors Engineering
QUALITY ASSURANCE (QA) ASSISTANCE
Human Factors Engineering
RDEC integrates Human Factors Engineering (HFE) into the medical device development process to enhance usability, minimize use-related risks, and ensure regulatory compliance. By focusing on user-centered design principles, we help clients develop intuitive, safe, and effective medical devices that improve patient outcomes and streamline healthcare workflows.