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
Optimizing Design with PTC Creo and Windchill Integration
Meeting the highest levels of product quality requires leading engineering and manufacturing teams to utilize integrated solutions. Bringing together advanced CAD and Product Lifecycle Management (PLM) capabilities can lead to lower costs and increased innovation....
Navigating the EU MDR Transition: What Medical Device Companies Need to Know
The EU Medical Device Regulation (EU MDR) transition is a significant regulatory shift that medical device companies must take seriously. Replacing the previous Medical Device Directive (MDD), the EU MDR (Regulation (EU) 2017/745) introduces more stringent...
Evaluating Arena and Windchill Key Differences for Scaling Product Development
As companies grow and product complexity increases, selecting the right Product Lifecycle Management (PLM) system becomes a critical decision. Two of the most widely used PLM platforms—Arena and Windchill—offer distinct approaches to managing product data, enabling...
The Ultimate Checklist for Managing CAD Success
CAD data management is not always easy. This checklist explores how a structured process can help ensure all data is secure and accessible. Let’s dive more into what drives CAD data management success.What You Will Learn In this eBook you will discover how to: Select...
The Role of PLM in Streamlining Product Development for Regulated Industries
Regulated industries face immense complexity in designing, producing, and maintaining high-quality products. Balancing this while ensuring compliance, managing data, and accelerating innovation is not possible without the proper tools. That’s why Product Lifecycle...
How Cloud-Based CAD Is Changing the Future of Collaborative Design
Traditional desktop-based CAD tools, while powerful, can have a hard time meeting the growing demands of modern engineering teams. They need better connectivity, scalability, and flexibility. That’s why cloud-based CAD (Computer-Aided Design) is quickly becoming the...
Innovative Uses of Google Workspace in Product Development Cycles
As new technologies arise, product development teams are under increasing pressure to innovate faster, delivering higher-quality results. The tools these teams use can make or break the development process. Google Workspace is a flexible, cloud-native productivity...
Accelerating Product Development with a Unified Digital Thread in PTC Windchill
Innovation-driven industries require fast-moving, collaborative product development cycles to stay competitive. From aerospace to medical device production, uncompromising compliance is the goal. Disconnected systems, siloed data, and manual workflows can’t keep up...
Nationwide Upgrade of Critical Medical Devices for Enhanced Hospital Operations
Medical device manufacturers know how rapidly technologies can change in the field. Ensuring you provide hospitals with innovative tools that meet regulatory requirements is vital. When a leading medical device manufacturer needed help upgrading software and hardware...