Medical

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.

Results:

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

Regulatory:

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.