Medical Device Engineering Experts
Efficiently getting your medical devices to market while meeting your compliance needs.
Medical device organizations face increasing pressure to accelerate innovation while maintaining strict regulatory compliance, product quality, and end-to-end traceability. SPK and Associates helps manufacturers modernize engineering and quality operations through integrated PLM, QMS, ALM, DevOps, cloud, and data engineering solutions that support FDA requirements, ISO 13485, FDA 21 CFR Part 11, and connected digital thread strategies. With over 20 years of experience supporting regulated engineering environments, we help medical device teams improve collaboration, streamline validation processes, and bring safer products to market faster.
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.
Common Medical Device Consulting Services
Engineering Operations
We can manage your MCAD, ECAD, 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.
CSV and CSA Support
We support CSV (Computer Systems Validation) and CSA (Computer Software Assurance) processes for IT applications and infrastructure management. Our regulatory experts help organizations reduce compliance risk and operational costs across validated environments.
eQMS Services
We can implement, manage, migrate, or upgrade 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 QMS & PLM system efficient and compliant.
Key Medical Device Client Successes
Medical Device Industry Related Resources