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
"SPK has been an invaluable partner in transforming our software development process. With SPK's guidance, our team embraced efficient methodologies and cutting-edge tools, significantly improving our development cycle and product quality."
Joshua Talbert
CEO, mysherpas
"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."
Jay DiToro
Director of Systems & Technology, Veranex
"The personalized attention and detailed communication we receive working with SPK and Associates is pretty special. The accessibility of SPK team members is impressive."
Evan Bruck
Director, Active Device Research and Development, BBraun Medical Inc.
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
Leveraging Windchill PLM for Effective Parts Classification and Supplier Integration
Efficient parts classification and supplier integration are critical for streamlining operations and enhancing product development. Utilizing the proper tools can ensure your organization achieves these results. PTC’s Windchill PLM offers a robust solution that allows...
Streamlining Your Data Ecosystem to Reduce Costs
Managing data across multiple systems can quickly become complex and overwhelming. This issue is common for companies across industries. Trying to manage all product-related data and CAD designs across multiple PLM and ERP systems often results in siloed data. This...
Leveraging Windchill PLM for Comprehensive Change Management
Change management, though necessary, can often be a difficult process involving multiple teams and data handoffs. Managing product, system, and process changes to meet organizational goals doesn’t have to be complicated. Utilizing a PLM solution such as PTC Windchill...
Optimizing Solidworks PDM Implementation
When multiple employees of a Fortune 100 medical equipment manufacturing company reached out to us for support with workflow functions and permissions, we knew there was a better way. Rather than fixing the issues that would inevitably keep occurring with their...
Application Management Reduced Testing Time from Days to Under One Hour
When a global leader in infusion therapy, pain management technology, and support was developing more complex systems, they required an effective design control solution to support those efforts. SPK stepped in to help the medical company implement Windchill...
Transforming Product Development with Configuration Management
When developing products, there are many components to keep track of such as parts, data, and configurations. Keeping up with every minor alteration to a product can be difficult, but using a PLM system like PTC Windchill can help you stay organized. Configuration...
Achieving the Speed of Innovation and Maintaining Compliance in the Medical Device Industry
Innovation is essential for staying ahead of competition in all industries, but especially in healthcare. Staying up to date with new technologies and compliance needs can improve outcomes for patients. The best way to ensure compliance is by utilizing the proper...
Five Major Downsides of Changing Software Tools
Switching to new software tools can often seem like an exciting opportunity to streamline processes, increase efficiency, and modernize operations. Some executives seem to think that simply buying a new software tool will solve many problems at once. However, with...
Accelerating Medical Device Development with the Digital Thread
The medical device industry is one of the most regulated industries due to the importance of the products they manufacture. Efficiently producing high-quality products that comply with regulatory standards is the key to successful medical device manufacturing....
