Medical Device Industry
Efficiently getting your medical devices to market while meeting your compliance needs.
Medtech suffers from twin pressures. On the one hand you have to get your products to market faster than the competition or you’re playing catch up. On the other hand, you have to make sure everything is of highest quality and meets FDA regulatory requirements. These two challenges, plus increasing globalization and increasing product complexity can be a daunting task to say the least.
For 20 years we’ve been helping medical device and life science companies bring their cutting edge medtech to market while meeting FDA standards. We do that by leveraging our product engineering expertise, deep IT experience, and thorough knowledge of current FDA regulatory requirements. That means a more efficient development cycle for your organization.
For startup or SMB Medtech companies, we can provide fully outsourced IT managed services, if needed. Wouldn’t you rather entrust your technology management to a partner that knows your industry inside and out?
What our clients say
Their talent is top notch and augments and deepens our engineering capabilities in technical areas where we lack expertise and cannot add dedicated personnel.
Working with SPK feels like working with co-workers in my company, not like interacting with a typical technical support vendor. SPK staff are responsive and partner with me.
The personalized attention and detailed communication we receive working with SPK and Associates is pretty special. The accessibility of SPK team members is impressive...
How we cater to the medical device industry
Integrated & compliant product engineering & lifecycle management
We can manage your MCAD, EE, and software engineering applications, supporting your FDA compliant design control procedure. With over 20 years of experience in medical device companies, our team has the expertise needed to support you.
Validated applications and computer systems
Quality Management System implementation & management
We can manage your QMS system and integrate with your product lifecycle process and applications. Our unique value is that we have integrated different applications over the years to make your PLM system efficient and compliant.
Key Medical Device Software Partnerships
Related Medical Device Industry Resources
Medtronic & PTC Codebeamer Case Study
The Neuromodulation department of Medtronic is a global leader in medical technology. Recently, they implemented codeBeamer ALM to overcome issues. These were issues that their previous software ecosystem wasn’t able to efficiently address. The organization aimed to...
What is CodeBeamer and CodeBeamer X?
In April 2022, PTC acquired Intland Software, the maker of CodeBeamer and CodeBeamer X. Codebeamer is an excellent tool for global leaders and innovators in regulated industries like Medical Devices. Its core purpose is to simplify product engineering and assist in...
Solve 4 System Design Bottlenecks And Accelerate Product Development
Are you satisfied with the speed of your product development? It’s rare I’ve heard an engineering team say that their development and release cycle velocity was “good enough”. Yet, time to market is so important for companies. So, like the track runner, we’re...
How To Restore The Data Card And BOM Tab In SolidWorks
Hi everyone, I am Daniela and I am the SolidWorks and SolidWorks PDM SME for SPK and Associates. Today I wanted explain a setting that I actually had a tough time finding while working with a user. That is how to restore the Data Card And BOM Tab In SolidWorks. So,...
Do I Need An MSP (Managed Services Provider)?
I’m Chris McHale, CEO and co-founder of SPK and Associates. Over the years, I’ve watched businesses grow. And as they do, they sometimes begin to wonder, “do I still need an MSP?” Today, I want you to discover why businesses, regardless of size, need an MSP. You see,...
What is SOLIDWORKS PDM and How Does It Benefit Me?
SolidWorks Corporations was founded in 1993. In 1997 it was acquired by Dassault Systèmes. Today, it has amassed over six million ecosystem users from designers to drafters. It has become globally accredited as an industry-leading parametric Computer Aided Design...
Engineering Digital Transformation Software — How Important Is It?
Engineering Software Market Trends 2022 Shows Surprising Growth Rates It’s fall, and ‘tis the season for market growth reports and forecasting. The Engineering software industry is surprisingly robust these days. Recent market research predicts a compound annual...
LastPass Business For Corporate and Client Security
At SPK, we want to empower employees to safely manage their own passwords. Additionally, for organizations, we want to enable the enforcement of password standards. Businesses that follow good password standards, such as increased complexity, non-duplicate passwords ...
Why You Should Be Using PTC Windchill As Your PLM Software
As a manufacturer, you have to be both structured and agile to constantly stay in line or ahead of the industry. You have to deliver quality products that meet the customer’s needs today whilst being future-proofed for tomorrow. Aside from that, you also need to...
