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About2019-05-28T10:50:17-04:00

Product Design + Manufacturing

Every product and company is unique, and once we understand you, your company and your unique product needs and goals we can get to work. Taking the time upfront is important, because innovation and optimization doesn’t just happen. Our team carefully and skillfully listens to you to understand everything you know about your product before setting off to design it based on your input, our own research, and any form, function, and cost requirements. We’ve designed products in nearly every product category and every industry, including medical devices, consumer products, transportation innovations, and defense and industrial solutions.

Even if we didn’t design and prototype your product, our innovative approach to contract manufacturing makes us the right partner to produce it. At Harbor Designs & Manufacturing we take the time to understand your mission, bottom line, technical details, and regulatory requirements. We put together a comprehensive manufacturing plan by competitively bidding global suppliers, auditing and qualifying those suppliers, defining production processing criteria, developing assembly instructions, and defining the incoming and outgoing inspection requirements to ensure your product is manufactured to the highest level of quality delivered on time, and on budget. We produce your product in a uniquely tailored turn key solution, so you can focus on what matters, running your business.

Services

We are innovators and creative problem solvers like you. We understand the challenges of designing and refining product and the path forward isn’t always clear or a straight line. With in house R&D we will set up experiments to challenge and test assumptions or ideas to inform and validate designs.

Our “top shelf” industrial designers and engineers are focused with the end user in mind, your customer. We create products with innovative form and function, so your product is attractive, unique and easy to use.

More than just a pretty picture, our team of experts design, refine and create the drawings to support the next level of your product. Design methodologies range from industrial and mechanical drawings to software designs.

Bringing your product to life is fun! We create marketing and working prototypes for you to raise capital, conduct critical market research and so we can mass manufacture your product to fulfill your sales pipeline.

We understand the essentials of combining innovative and state of the art software and technology solutions to match your products specifications. Producing safe and secure technology enhances your products sustainability.

We have global supply chain relationships, adhere to manufacturing best practices and quality ISO Certifications and FDA Requirements to manufacture your product to the highest standards so you can focus on your business.

Consulting Services

The benefits of strategic planning and execution with Harbor Design& Manufacturing Consulting Services

Navigating product development in today’s business environment is challenging enough. Harbor Designs & Manufacturing Consulting Services helps you plan and execute to minimize regulatory risks, improve quality standards and expedite speed to market. We have the expert resources you need, when you need it them. Consulting services range from Regulatory and Quality to International Business Consulting. In today’s world there is no need to navigating the unknown alone. Contact Harbor Design & Manufacturing Consulting Services and begin start the right start down the right pathway of success.

REGULATORY CONSULTING SERVICES

Are you seeking or need regulatory approval in the US or Internationally? Understanding regulatory requirements during the product development life cycle is important to having a successful commercial product deployment. We understand companies and their products enter the regulatory process at different times in the development life cycle and our team of experts can help guide and provide the direction you need. Providing you with a regulatory strategic plan which can reduce cost and expedite time to market.

US Regulatory Services
• Regulatory Strategy and Compliance
• FDA Q-Sub Process
• Investigational Device Exemption (IDE)
• 510(k)
• Humanitarian Use Designation (HUD) and Humanitarian Device Exemption (HDE)
• De Novo
• Pre-Market Approval (PMA)
• Expanded Access (Compassionate Use Request)
• Clinical Strategy/Study Design
• Medical Writing

International Regulator Services
• Regulatory Strategy and Compliance
• EU Medical Device Regulation (MDR) Remediation and Compliance
• EU Medical Device Directive (MDD)
• Clinical Evaluation Reports (CER)
• CE Marking
• Market Registrations and Filings
• Clinical Strategy/Study Design
• Medical Writing

QUALITY CONSULTING SERVICES

Building quality in during the design phase ensures manufacturing can be done efficiently and correctly. Harbor can provide an independent review of your product’s purpose relative to appropriate stakeholders. At the same time, we check to ensure design and contract requirements are relevant and on-topic with your stated market segment needs, saving your company money by documenting and building quality in at every stage of the product development process.

Want to ensure your product has been quality tested and meets your customer needs? Our Quality Consulting team provides testing design and support for validation testing. These tests are vital to show stakeholder requirements have been adequately addressed in your finished product. Quality Consulting services which can be provided by the Harbor Quality team consist of but are not limited to the following list.

• User Needs and Design Input Review/Validation Testing Support
• Conduct Independent audit/Review of your risk management file
• Risk Analysis Support
• Document Control Support (Greenlight Guru Software Access)

  • INTERNATIONAL BUSINESS CONSULTING

Does your start up need help entering foreign markets or plan to conduct clinical trials abroad? Its important to understand the cultures you are dealing with, do you kiss, bow or shake hands when first meeting people internationally? Harbors has access to leaders who have worked are working and know how to guide you in working in the emerging markets. With the proper political understanding of State entities,  cultural awareness and working with the proper groups in nearby Washington DC and in country can help reduce your time to market and avoid costly mistakes.

Let us help you plan your international go to market strategy, whether you need assistance in finding the proper in country partners, meet with ambassadors or understand the protocols of embassies, and heads of state Harbor International Business Consultants have the global relationships and knowledge to boost your company to do business internationally. Not planned properly, these activities can end up being costly or detrimental to the success of your business. Let us help you design the proper strategic execution plan to successfully develop your business internationally in foreign markets.

• Global Strategy and Business Plans
• Cultural Awareness/Protocols/Preparedness Training
• Strategic Global Marketing, Branding & Sales
• International Finance

Years of Design and Manufacturing Experience

Our vision is to produce state of the art designs, “designed for manufacturing” prototypes and to manufacture quality products efficiently.

Bringing new products to market, re-imagining the old into new and helping you commercialize your ideas into great products is our goal.

Industries

The expertise to design, refine and commercialize.

Consumer Products

Medical Devices & Products

Transportation Solutions

Certifications

Harbor Designs and Manufacturing is registered by the American National Accreditation Board to ISO 9001:2015 (Quality Management for Commercial Devices) and ISO 13485:2016 (Quality Management for Medical Devices).

To achieve and maintain accreditation, Harbor has implemented a quality system that has planned design, risk and manufacturing controls. These controls are both efficient and effective to deliver a quality product, which allows our clients to quickly get to market. Harbor will be registered with the FDA as a medical device OEM by end of year 2019.

INSIDE HARBOR

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