Advanced Medtech Prototype Technology Manufacturing Solutions
We design and engineer production-ready medical devices that integrate electronics, mechanics, industrial design, embedded software, hardware development, and firmware development, taking you from concept validation to regulatory-compliant launch.
Reliable Engineering
MedTech With Pinetics
At Pinetics, we bring medical innovation to life—literally. We specialize in transforming early-stage medical device concepts into high-precision prototypes, ready for clinical validation and market entry. With state-of-the-art infrastructure and deep industry expertise in hardware development and firmware development, we ensure your ideas meet the gold standard in performance, safety, and regulatory readiness.
- 20+ Years of MedTech Experience
- Production-grade Prototype Delivery
- Round-the-clock Engineering Support
- Development aligned with regulatory and manufacturing readiness
Capabilities
How We Support MedTech Innovation
Ideation & Concept Engineering
We turn clinical needs into workable product concepts. Our approach aligns early ideas with medical device design and compliance, mitigating technical and regulatory risk.
- Clinical & User Needs Analysis
- Risk-Based Concept Evaluation
- System Architecture for Connected Medical Devices
- Design Input & Requirements Definition
Product Design & Development
Our MedTech Product Development teams specialize in medical device electronics, mechanical, industrial design, hardware development, and firmware development, ensuring reliability, traceability, and scalability.
- Embedded Systems for Medical Devices
- Electronics, PCB & Firmware Architecture
- Design Controls aligned with EU MDR & FDA QSR
Testing & Regulatory Alignment
We embed testing throughout hardware and firmware development to generate evidence aligned with Medical Device Regulatory Compliance standards. We support validation strategies that address CDSCO, EU MDR and US FDA 510(k) expectations.
- Verification & Validation (V&V)
- Electrical Safety & Performance Testing (IEC 60601-1)
- Usability & Human Factors Engineering
- Risk Management (ISO 14971)
SaMD Development
Software as a Medical Device
Software as a Medical Device (SaMD) is a standalone software developed to perform regulated medical functions such as diagnosis, monitoring, clinical decision support, or therapeutic guidance, without being part of a physical medical device. SaMD solutions typically operate on mobile, desktop, or cloud platforms and are central to modern digital health innovation.
Software as a Medical Device (SaMD) delivers regulated medical functionality entirely through software. Pinetics builds SaMD solutions aligned with global medical device standards, ensuring safety, performance, and compliance across the complete software development lifecycle.
Rapid Iteration
Test Hypothesis With Us
Our lab is built for iteration, functional testing, compliance, and validation across hardware development and firmware development. We ensure every prototype meets the demands of real-world use.
- Clinical-grade
- Biocompatible
- Environmental stress testing
- Documentation-ready results
MedTech Journey
How We Take Your Medical Device From Concept to Clinic
Concept & Feasibility
We help you translate clinical insight into a clear product strategy, running feasibility studies, risk mapping, and early proof‑of‑concept builds so only the strongest ideas move forward.
Design & Engineering
We combine human-centric design with rigorous electronics, hardware development, firmware development, and systems engineering to build architectures that are robust, scalable, and optimized with DFM and regulatory needs in mind from day one.
Rapid Prototyping
Using 3D printing, CNC, and production-grade electronics builds, we deliver fast design iterations with testable prototypes, enabling early verification, usability feedback, and technical risk reduction before you lock the design.
Verification, Validation & Compliance
From bench testing to pre‑clinical validation, we align documentation, risk files, and test evidence with CDSCO, EU MDR, US FDA and ISO standards so your device is ready for formal submissions without last‑minute surprises.
Manufacturing Transfer & Lifecycle Support
Our team prepares manufacturing-ready designs for hardware development and firmware development, supports vendor handovers, and helps maintain post-launch updates.
Your Dependable Partner
Why Pinetics Leads the Way
With 20+ years of MedTech expertise across our leadership team, Pinetics stands out as more than just a prototyping provider—we are your dedicated innovation partner. Our strength lies in deep domain knowledge, adoption of cutting-edge technologies, and an unwavering focus on personalized client service, ensuring every solution is tailored for precision, compliance, and real-world impact.
Core Capabilities:
- ISO Certification
- Advanced Engineering
- Rapid Prototyping
- Regulatory Compliance
- 3D Printing
- Usability Testing
- Documentation Support
Expertise
Our team comprises seasoned professionals with 20+ years of experience in the MedTech industry.
Technology
We are known for using cutting-edge technologies & methodologies to deliver high-quality prototypes quickly & efficiently.
Customer Focus
We prioritize our clients' needs, offering personalized services and support throughout the prototyping process.
FAQ
Frequently Asked Questions
Pinetics helps MedTech companies build reliable medical device hardware—covering electronics design, embedded firmware, connected systems, and validation—ensuring products are safe, compliant, and ready for real-world clinical use.
Yes. We design and develop regulated medical device hardware, including electronics, PCB design, and embedded systems, with quality and regulatory requirements considered from the earliest design stages.
Absolutely. We frequently work with early-stage teams to convert clinical ideas into engineered prototypes, define system architecture, and create a clear path toward regulatory approval and manufacturing.
We take IP protection seriously. Every engagement is backed by robust non-disclosure agreements (NDAs), secure communication protocols, and access-controlled R&D zones. Our digital infrastructure is built to prevent data leaks, and all files are stored in encrypted environments.
Yes. Beyond prototyping, we help clients scale with confidence. Pinetics has a vetted network of ISO-certified manufacturing partners for low-volume production, pilot batches, and design-for-manufacturing (DFM) iterations.
Yes. We design medical device hardware using regulatory-driven development processes, integrating documentation, risk management, design controls, and traceability into electronics and embedded system development from the outset.
Yes. We build functional medical device prototypes and carry out verification and validation activities to ensure the hardware and embedded systems meet defined requirements, clinical use expectations, and regulatory needs.
Contact
Contact Us
Got a MedTech idea? Let’s build it right through hardware development and firmware development faster, smarter, and fully compliant.
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