medical device design
& development
& development
Technology Development
Whether you have a clinical problem, device idea, product or process development problem, Precise Device Solutions has you covered. We combine experience, innovation and unequalled focus on customer needs to attack the problem and product results.
we’re the solution to your problem
Technology Development / Product Design
If the solution to your need is unidentified Precise Device Solutions has you covered. Precise Device Solutions has a track record of turning white paper into proven products. To solve such problems, we engage in:
- Identification of customer needs
- Problem definition and decomposition
- Identification of technical and customer boundaries
- Fast, collaborative, and iterative design cycles
- Functional and non-functional prototyping
Consulting / Contracting / Staffing
If the solution to your need is unidentified Precise Device Solutions has you covered. Precise Device Solutions has a track record of turning white paper into proven products. To solve such problems, we engage in:
- Identification of customer needs
- Problem definition and decomposition
- Identification of technical and customer boundaries
- Fast, collaborative, and iterative design cycles
- Functional and non-functional prototyping
Development / Design Controls
With the increasing complexity of clinical needs and medical devices, a thorough understanding of the product development life cycle and design controls process is a must. At Precise Device Solutions, we start with the end in mind.
- Design and Development Planning
- Design Inputs
- Design Outputs
- Design Validation and Verification
- Design Transfer
Process Development / Validation
A wealth of experience with established firms performing process validation and Six Sigma has resulted in efficient process development and validation, as well as, effective problem solving.
- Gauge repeatability and reliability (guage R&R)
- Test method validation (TMV)
- Installation qualification (IQ)
- Operational qualification (OQ)
- Process and performance qualification (PQ/PPQ)
- Six Sigma DMAIC and problem solving processes
Quality Systems / Risk Management
A thorough understanding
- 21 CFR 820, ISO 13485, ISO 14971
- Standard Operating Procedures
- Change Control
- Risk Assessment
- Failure Mode and Effects Analysis
Project / Program Management
Precise Device Solutions can handle all of your project management needs. We can help with:
- Scope Definition
- Work Breakdown Structure and Gantt Charts
- Status Reporting and Earned Value Management
- Communication and Risk Management Plans
- Vendor and Customer Management
Precise Device Solutions
Vision
Our process of design and development begins with the end in mind. We don’t just design for manufacturability, we design for the customer, quality, and the regulator.
Mission
Connects health care companies, clinicians, and investors with cutting edge technology, creative design, and efficient problem solving in order to address clinical needs with effective and innovative solutions.
About the founder
Precise Device Solutions founder, Tim McSweeney, has been solving medical device design, development, and manufacturing problems for over a decade. He spent his childhood at his father’s art studio where he fostered a creative and inquisitive intellect. Early on, his design and engineering skills were demonstrated in his technical drawings of boats, bridges, and automobiles. These technical and creative skills combined with work ethic, were demonstrated when Tim had the opportunity to build his own boat under the guidance of master boat builder, Tiffany Cockrell.
Contact Us
info@pd.solutions
2916 SW 8th St, 33135 – Miami, FL
804.387.3815
804.387.3815
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Při výběru spolehlivé, prověřené a dlouhodobě stabilní herní platformy se řada českých hráčů z celé republiky již několik let spoléhá právě na zahraniční casino online, protože nabízí ověřené licence, rychlé výplaty výher a širokou nabídku automatů i živých her pro všechny úrovně zkušeností a pro každý herní styl.