iNTEGRAL Data Management Systems helps medical device companies architect, manage, and control their engineering data inside SolidWorks PDM — with precision built for regulated environments.
iNTEGRAL Data Management Systems was founded on a simple conviction: data architecture is not an afterthought — it is the foundation on which compliant, scalable product development is built.
For over three decades we have partnered with medical device manufacturers to design and implement SolidWorks PDM environments that meet the stringent demands of FDA regulations, ISO 13485, and 21 CFR Part 11. Our team brings deep expertise in both the technical and regulatory dimensions of data management.
From greenfield PDM implementations to complex vault migrations and custom tool development, IDMS delivers solutions that are built to last — and built to pass audits.
Vault design and implementation built for regulated environments from day one.
Deep knowledge of FDA QSR, 21 CFR Part 11, and ISO 13485 requirements.
Purpose-built PDM add-ins and tools that solve your specific workflow challenges.
Hands-on training and long-term support to keep your team and vault performing.
From initial vault architecture through ongoing support and custom software development, IDMS covers the full lifecycle of your PDM environment.
We design PDM vault structures from the ground up — folder hierarchies, naming conventions, metadata schemas, and card layouts tailored to your product development process and regulatory requirements.
Custom approval workflows, lifecycle states, and transition conditions that enforce your ECO/ECR processes and maintain a compliant, auditable change history inside PDM.
Purpose-built SolidWorks PDM add-ins that automate repetitive tasks, enforce data quality, and extend PDM's capabilities to match your exact operational needs.
Structured migration of legacy data into PDM, including file re-linking, metadata mapping, and version history preservation. Upgrade support for major PDM version transitions.
IQ/OQ/PQ validation support for 21 CFR Part 11 sites. We help document and execute your PDM system validation to satisfy FDA and ISO audit requirements.
Role-based training for administrators, power users, and general users. Ongoing support retainers to keep your vault healthy and your team productive as your needs evolve.
Built from 35 years of experience watching medical device teams struggle with DMR assembly — Fastlink is our answer.
Our deepest expertise is in medical devices, but our PDM and data management skills serve any regulated manufacturing environment.
Class I, II, and III device manufacturers navigating FDA QSR and ISO 13485 requirements.
Drug-device combination products requiring coordinated documentation across both regulatory frameworks.
AS9100 and ITAR-compliant engineering data management for aerospace manufacturers.
Complex mechanical product companies that need robust PDM structure to manage large assemblies.
Whether you're starting a new PDM implementation, struggling with an existing one, or want to see Fastlink in action — we're here.
Tell us about your current environment, your team size, and your compliance requirements. We'll put together a tailored approach.
See Fastlink live against a sample PDM vault. We'll walk through DMR assembly, extraction, and markup in about 30 minutes.
Questions about our services, pricing, or team? Reach out and we'll get back to you within one business day.