Medical device product development, from concept through commercialization, integrating business needs, regulatory requirements and processes.
Nectar strives to ensure patient safety and product equity.
Nectar provides full service medical device development, transforming a technology concept, through design, manufacturing transfer and regulatory approvals, to a viable commercial product. We develop leading-edge medical devices for start-ups and established biotech biotech companies. Our development process follows ISO 13485 and FDA’s-, 21 CFR, Part 820, Quality System Regulation, to ensure expedient regulatory approvals.
- A safe and efficacious product
- Entry into new markets & increased profitability
- Minimizing business risks
Medical Device Development Services:
- Translation of product requirements into design specifications
- Concept development
- Risk management, including hazard analysis and FMEA
- Device development for manufacturability & serviceability
- Ergonomics and human factors engineering
- Functional and marketing prototypes
- Biocompatibility & shelf life testing
- Sterilization Validation
- IEC 60601-1 Testing
- Design Verification & Validation testing
- Usability Testing
- Design History File (DHF) documentation
- Packaging design and testing
- Manufacturing Process development and validation
- Manufacturing Device Master Record (DMR)
- Automated test and assembly equipment development and qualification
- Supplier selection and qualification
- CE Technical File
- 510(k) preparation
- Canadian Medical Device License
We provide medical device development services under our customer’s product development process or according to our own ISO 13485 & QSR compliant process. We ensure compliance with regulations through a collaborative development process with our customers.
Six-stage, Phase-gate Product Development Process:
- Product Definition
- Product Specification
- Detailed Design
- Design Verification
- Product Validation
- Manufacturing Design Transfer & Product Launch
Nectar can engage with customers from product concept through commercial launch or during any of the above development phases. Device classification and regulatory path are factored into each project. We maintain constant communication with our clients throughout each project and hold formal design reviews to close each phase, where we collectively review design inputs and outputs.
Our project deliverables are:
- A complete compliant Design History File, with all specifications, test documentation, and traceability matrix,
- Formalized and validated manufacturing processes, and
- Regulatory submissions and/or CE Technical File, as applicable.
Our experience across numerous device types, both durable and consumable, and our focus on engineering excellence, allows us a unique advantage to help our customers minimize development risk and bring first-in-class devices to market.
While Nectar does not offer production services, our Quality Management System does include setting up manufacturing processes with associated documentation and training at a qualified contract manufacturer.
Selected medical device projects:
- Branding Architecture / Medical Device Implants
- Breath Coordinated Inhaler
- CPAP Nasal Mask
- Cardiopulmonary Function Testing System
- Clinical Patient Monitoring Device / Cable Management
- Disposable Hand held Medical Dispenser
- Disposable Point of Care Rapid Diagnostic Platform
- Endodontic Irrigation System
- Endodontic Surgical / Apex Finder / Root Canal Device
- Home Care Patient Ventilator
- Immunoassay Platform for Point of Care
- Integrated Patient Care Platform for the Military
- Integrated Patient Care Platform for the Military / DARPA
- Retima Imaging System
- Wirelss x-ray digital panel
- Disposable hemostatic clip applier
- Disposable skin stapler
- Non-invasive trans-nasal cooling system
- Ultrasonic imaging and ablation for detection and treatment of prostate cancer
Nectar has developed a Quality Management System (QMS) that applies to our internal Product Development Process and may be integrated with customers’ processes. Our QMS is compliant with the ISO 13485, ISO 9001, and with FDA’s QSR requirements.