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We are proud to announce Goddard has received ISO 13485:2016 certification!

After more than 20 years of developing high-quality medical technology, we have taken our capabilities to the next level.  By adding a rigorous quality system to our product development process we now offer a complete service set to develop medical devices from concept to production and beyond.  This certification ensures our broad range of capabilities deliver strong value to our current and future clients.

Need to add quality assurance and regulatory affairs experts to your team? 

Have a new medical device or life science engineering project? 

Contact us to learn more about our capabilities and how our ISO 13485 certification can benefit your product development projects.

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Why is ISO 13485 Certification Valuable for Medical Device Manufacturers?

The medical device industry is one of the most highly regulated verticals worldwide. Devices and quality systems must satisfy stringent requirements before they can be marketed and sold in the U.S. and worldwide.

The ISO 13485:2016 standard specifies requirements for a quality management system (QMS) for an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. By certifying your QMS, you can better market your products, and improve your organization’s level of efficiency.

The standard requires that the certified organization can demonstrate that their QMS is implemented effectively and that it is maintained. You do this through documentation that proves you not only have processes in place but that you also follow them.

Why Seek ISO 13485 Certification?

Achieving an ISO 13485 certification has significant benefits to your company, whether a large organization or a startup. It systematizes processes that may already be in place for quality assurance, mitigates risk by ensuring your product is safe for its intended use, and can accelerate speed to market within a stringent quality and regulatory framework. 

Fundamentally, certification establishes a strong foundation before venturing into the highly regulated medical device approval process.  Going through certification ensures a focus on risk management and design control activities during the product development stage. It creates monitors and controls in the work environment to ensure product safety.

ISO 13485 is considered the most common path to meeting requirements to market and sell your device worldwide. For example, compliance with this standard is considered to be the first step in achieving compliance with European regulatory requirements.

Who Needs ISO 13485 Certification?

Medical device manufacturers and anyone who intends to market and sell their products globally can benefit from ISO 13485 certification. However, even companies who provide services to device manufacturers can benefit.

Goddard, for example, sought ISO 13485 certification to better align to our client’s needs and formalize our rigorous product development process.

Whether your company is focused on production, design and development, installation, or servicing of medical devices, ISO 13485:2016 is relevant to your business.

Benefits for Startups and Small Organizations

Achieving ISO 13485 certification can be an arduous process. If you’re managing a startup speed to market matters, and a well-functioning QMS can be a catalyst rather than a burden.

Product design becomes more efficient when definitions of product requirements and quality processes are standardized. Well executed, ISO 13485 should reduce re-work, and drive better execution. 

If you need guidance with the certification process, Goddard can help. Our R&Q team has already gone through it, and can assist in setting up quality processes per the ISO 13485 standard. Or, your organization can leverage Goddard’s quality system to speed product development until the time is right to transition to an in-house certified QMS.

Some countries require ISO 13485 certification to support regulatory approval, so depending on the markets where you intend to sell, this should be an early consideration.

For Large Organizations with an Established QMS

If your company already has a quality system in place, there are benefits to working with a product design firm that is ISO 13485 certified. First, Goddard is able to interface with your organization’s existing QMS. More importantly, having a second, outside set of eyes is useful for identifying opportunities for improvement in your QMS. By spotting any non-conforming areas, you can minimize the associated risks before they become a problem.

In large medical device organizations, an ISO 13485-certified QMS is likely already in place. It’s an important part of defining and controlling operations and product development.

When engaging external technical teams, a quality certification indicates an understanding of regulatory requirements and experience operating in a controlled system. Likewise, an external R&Q team is often able to identify opportunities for improvement within a QMS.

ISO 13485 Certification Can Help Avoid Device Recalls

According to the FDA, the number one benefit of achieving and applying ISO 13485 certification lies in avoiding recalls. The FDA also reports that between 40-50% of all medical device recalls are related to flaws in product development. 

Unfortunately, 2018 saw a spike in medical device recalls.  While the root causes vary, risk management is consistently linked to QMS structure and compliance.  A functioning system supports the definition of user inputs and product requirements, controls on supplier processes, and appropriate overall management of the product development process. Of course, a QMS does not eliminate risk of recalls, but it plays a significant role in reducing that risk, and producing high quality, safe products.

Improving Business Performance through ISO 13485 Certification

Going through the certification process pushed the Goddard team to thoughtfully assess business performance and critical contributing factors.  Part of Goddard’s 13485 quality metrics include measuring company growth, employee satisfaction, and success in addressing customer needs.

Goddard implemented a rigorous approach to measuring client and partner satisfaction, leveraging both surveys and periodic, less formal check-ins.  Analysis of structured and unstructured datasets established an impartial representation of key stakeholder opinions and led to actionable results.

The certification process also includes tracking employee development, advancement and satisfaction. Again, a data-centric and controlled approach led to new learnings in accelerating team development, and early identification of issues. 

In concert with end-to-end product development services, Goddard is well positioned to address challenges in the regulatory and quality space, and support the establishment of effective ISO 13485-compliant quality management systems. 

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The design of the Company is intentional and proves its effectiveness repeatedly.  We believe in our employees, we believe in educating them, mentoring them, paying them what they are worth, promoting them, and this sets a solid course for them to grow with the Company.  The Company understands our only true assets are our employees.  Let’s be honest- we are a service provider.  We don’t sell a widget, we sell solutions.  The understanding that every employee is an individual and is to be carefully paired with a client is paramount to the continued success and happiness of every employee and client.  Knowing how to do this dance is ½ the effort, the other ½ is maintaining the culture.  The company strongly believes “everyone has a voice, and everyone should learn to use it”.  A level playing field is paramount.  We don’t put too much weight in titles, we hold regular company meetings, off-site beer Tuesdays, summer Fridays and a true open door policy with everyone. These are the values our leaders consistently strive for.  Maintaining a comfortable, energetic, fun, no-judgment workplace will promote good, healthy employees.

When I started this company I had a belief that good, solid engineering and design work coupled with strong communication and problem-solving skills would be a cascading, and expanding force.  If I did a good job, made the client successful, the reward would be more work.  That belief is still true today.  Our pairing of Employees skill set, personality, experience with our clients is a skill we take pride in.  Most of our projects are from repeat clients, that keep coming back with additional projects.  This continued repeat work, coupled with our employee retention history proves to us that we are onto something big here.

As Charlie Munger, Warren Buffett’s right-hand man says: 

“Three rules for a career:

1) Don’t sell anything you wouldn’t buy yourself.

2) Don’t work for anyone you don’t respect and admire.

3) Work only with people you enjoy.”

Hire for passion first, experience second, and credentials third.

From the desk of Andrew Goddard, Owner and CEO

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Our expert panel of product developers will share experiences and lessons learned in making product development and engineering decisions. We often need to make critical decisions with incomplete information or conflicting data. In this webinar the panel assembled will help you evaluate challenges and risks to yield effective decision-making strategies. The Goddard team will analyze and strategize with your team in real time to guide your product development efforts.

By attending this webinar you will:

  • Evaluate risks and make effective product decisions
  • Learn new strategies for making decisions with incomplete information
  • Understand when to call in outside experts
  • Better understand risk management with a focus on critical items

Register Here!

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In appreciation of Cummings leasing relationship with client firms of more than 20 years, Cummings has started a new program called Client Directed Giving Program. This program is modeled after their Employee Directed Giving program and Cummings Properties will continue to contribute $1,000 on Goddard’s behalf as long as Goddard remains in the Cummings building. Goddard got to choice a local charity and match Cummings Properties contribution of $1,000.                            

Goddard Technologies, Inc. chose an organization located at the Cummings Center, Express Yourself, Inc. This organization brings creative arts programs to the youth in residential and outpatient treatment facilities within the community and throughout MA. Goddard contributed $1,000 and Cummings Center matched their donation with $1,000. The check was presented to Paula Conrad, Founder and Co-Executive Director of Express Yourself.  Paula informed Goddard that C.F. Adams Charitable Trust, which focuses on children’s behavioral health in MA, will match any donation that Express Yourself receives. As a result of Goddard’s and Cummings’ combined donation of $2000, Express Yourself will also be receiving an additional $2,000 from C.F. Adams Charitable Trust. This year marks 25 years of performances celebrated by Express Yourself, EXY025!

It’s an amazing feeling to be part of a company who supports an organization that sincerely makes a difference in the life of Express Yourself youth.

 -Tara Colameta, Accountant & Brenda Comeau, Executive Administator

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We are proud to be Gold Sponsors of this years DeviceTalks event in Boston. This event always delivers valuable insights from industry insiders and fantastic networking opportunities. Register here: https://bit.ly/2QuGdIC

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Goddard is excited to exhibit at the 2018 Advamed Medtech Conference.  Our team will be there to learn from the senior leaders of the MedTech community and discuss our growing capabilities.  We recently implemented an ISO 13485 quality system and are planning for certification later this year.  Please visit us at booth #223 to learn more about our quality system and growing product development service portfolio.

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I would like to share a little bit about my daughter, Christina (age 9), who was diagnosed with an Astrocytoma tumor in her spinal cord in 2014. The tumor was approximately 5cm tall and 2cm wide – officially it ranged from the T9 to the L1 in her column. It was labeled as “mixed,” exhibiting both benign and malignant features. She had a nine-hour surgery to remove it, but unfortunately, the surgeons weren’t able to get it all as the bottom portion of the tumor was infiltrating her cord.

We are fortunate to be at MassGeneral Hospital (MGH) since they are one of only two hospitals in the world with a proton-based radiation machine. This technology allows healthcare professionals to focus the radiation energy within millimeters of the target, drastically reducing the risk of harming anything surrounding the tumor. Due to Christina’s age, radiation won’t be performed on her until she’s in her early teens. In the meantime, she is undergoing chemotherapy and has had a second surgery to implant a port under her skin in order to administer the treatment.

Since 1998, in partnership with John Hancock Financial, the MGH Marathon Team has raised nearly $11M to support the pediatric hematology-oncology program at the MassGeneral Hospital for Children. Funds raised are directed toward cancer care and research initiatives that enhance the quality of life for the hospital’s youngest cancer patients.

The MGH Marathon Team is centered on the Marathon Patient-Partner Program, in which runners are paired with patients undergoing cancer treatment at MGH. When the runners set out on Boston’s grueling 26.2-mile course, they not only raise funds and awareness for pediatric cancer research, they inspire and bring hope, especially for us. Christina and our whole family will be cheering on our runner – who is a survivor, having been diagnosed with a similar tumor as Christina’s at age 4 – and the whole MGH team. Click here for an article on the runner who Christina is matched with; her story is inspirational and she brings an abundance of optimism to us, in addition to being someone whom Christina can look up to.

Working as an Accountant for Goddard, I’m always intrigued to hear about the variety of products that we design and how they are engineered – especially when it comes to the many medical devices that the company works on. This exposure continuously widens my breadth of knowledge. Through Goddard and our experiences over at MGH combined with Christina’s dad being an R&D engineer who also brings medical devices to life, I’m constantly gaining new information and better understanding that I’m able to impart upon my family.

If you are interested in supporting the MGH Marathon Team, you can donate now by clicking here to sponsor Christina’s runner.

-Tara Colameta, Accountant

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