MEDICAL DEVICE DEVELOPMENTFrom concept to manufacture

The landscape for medical devices is changing. Regulatory compliance is becoming more challenging, new technologies are expensive and skilled employees are difficult to find. The leading medical device companies are outsourcing more areas of the design and manufacture process in order to sustain competitive advantage - can you afford to gamble with your product development?

Transform the way you work – with Emblation.

www.emblationmicrowave.com

INDUSTRIAL, SCIENTIFIC AND MEDICALem blation microwave

You need - INNOVATIVE DESIGN. A meeting with us at the start of your project can dramatically cut time to market and reduce the risk of any compliance issues in the later stages of design. We connect the user needs with a solid regulatory strategy and provide a turn-key solution for any skills gaps in your organization.

You need - ADVANCED TECHNOLOGY. An investment in the latest technology means you can out-source any aspect of your product design and we will manage the process for you. Our dedicated team can provide expert skills in industrial design and we can move quickly and autonomously, streamlining your development and getting you to market faster.

You need - RELIABLE MANUFACTURE. Emblation will manage your development and manufacture needs from single build prototypes up to volume production in compliance with ISO 13485.

We offer full design, development and manufacture services through our facility in central Scotland. By outsourcing all or part of your product development you can utilize our core expertise and extensive design experience – leaving you to concentrate on running your business.

THE EMBLATION ADVANTAGE OUTSOURCING INTELLIGENCE

CAPABILITIES

Formal Design ControlDesign DevelopmentProduct SpecificationConcept GenerationQuality – ISO 13485FDA QSR

ManufactureFull Hardware inc PCB, Enclosure, Wiring

Transfer to ManufactureManufacture DocumentationManufacturing Line SetupProcess ValidationSterilization Validation

Risk Management to ISO 14971Documentation creation (user manuals, IFUs)Regulatory preparation and submission

Electronics and SoftwareMedical Device Software (including experience of high risk class III devices in the US)

Electrical Safety to 60601 (3rd edition)Stress AnalysisShipping Validation (ISTA 2A)

HALT/HASS TestingEnvironmental TestingErgonomicsEMC Testing

Prototype DevelopmentPackage DesignLabel DesignGraphic DesignAnimated product visualsProduct Illustrations / visuals

We provide expert skills in all of these areas - saving you the continued

expense of maintaining an in-house design team

Industrial DesignElectrical Design (PCB)CAD Design3D Mechanical DesignSimulation and ModellingThermal DesignDesign for EMCColour, Material, Finish

PROCESS

Product Validation

Our design philosophy ensures product validation is planned from the point of product conception. This strategy identifies the technical and clinical requirements that need to be met to ensure regulatory approval is completed quickly and efficiently.

Emblation employs established design control procedures to ensure that products are developed to comply with risk management, quality and regulatory requirements. All aspects of design including industrial design, human factors and reliability are incorporated from the outset.

Design Control Manufacture

Emblation will manufacture your products from prototype development through to volume production in compliance with ISO 13485. Our team will ensure that the manufacturing process is fully validated, ensuring your finished products always meet your customer’s satisfaction.

Quality & Regulatory

Emblation operates under an ISO 13485 and ISO 9001 certified quality management system. Our comprehensive approach to quality challenges all processes to ensure products are delivered to the user and always meet the highest regulatory standards.

We implement industry standard risk management practices that continue throughout development, manufacturing, product release and market surveillance. This risk based approach ensures that correct processes and procedures are used to ensure a safe and effective product.

Product Safety

ABOUT EMBLATION

Emblation is a medical device company founded on solving difficult problems. Established in the USA in 2007, the company then relocated to Scotland the following year to continue research into novel microwave based medical products. Utilizing our next-generation microwave platform, we have manufactured and launched a range of innovative products for a number of global markets. Our systems include several unique features, making our products some of the safest and most advanced systems available today.

Emblation has a dedicated product development team trained in the use of state of the art software and modelling tools. With a wealth of experience in the design, development and manufacture of market leading products, Emblation is certified to ISO 13485 and ISO 9001 standards for design and manufacture and is committed to providing next generation solutions for today’s innovative medical device organisations.

Emblation MicrowaveForrester Lodge, Inglewood, Alloa

Scotland, UK, FK10 2HUUS Tel: +1 (781) 577 2796UK Tel: +44 (1259) 236132

UK Fax: +44 (1259) 210430info@emblationmicrowave.comwww.emblationmicrowave.com

An Emblation Limited Company

INDUSTRIAL, SCIENTIFIC AND MEDICAL

MRK11, Issue 1 Medical Product Development Brochure