Summary
- Why Seal
- Seal has no fixed model of one kind of work. It is built from primitives: record types, the relationships between them, and the steps and checks that use them, which your own team composes into your process, with Neil able to prepare each change for approval. So one platform runs process development, the laboratory, manufacturing, batch release and the quality system, and each change becomes a new version, released once its selected tests pass, while earlier runs keep theirs. Design inputs, risk controls, verification and each change sit on the same records as every unit’s build record, the quality system and training, so a design change shows the units it reaches.
- Results
- Moving from paper and legacy systems, Paradromics cut operator paperwork by 80% and engineers’ traveler review time by 90%. “Since implementing Seal, we’ve reduced operator paperwork time by over 80%, allowing our team to focus on core process improvement. I am hugely excited about the next stage of utilizing the system to query a single, unified set of data to find further opportunities for process development.” Donald Savacool, Process Engineering Manager, Paradromics.
1What to check when choosing.
- Is the traceability matrix a view of links made as the design is developed, or a document assembled before an audit?
- Does a design change show the units already built that it reaches?
- Are the device history record, complaints and CAPA on the design’s records, or in another product?
- Does its AI check wording, or prepare the change for your team to verify and approve?
- Which of your engineers’ tools does it connect, and which system holds the approval?
Each product’s comparison sets out, with its sources, how it answers these and how Seal does.
References
- 1AI-Native Continuous Compliance for Regulated Development, Ketryx. https:/
/ www. ketryx. com/ product (read 13 November 2026) - 2Product Context Layer for AI & Requirements Management, Jama Software. https:/
/ www. jamasoftware. com/ (read 13 November 2026) - 3Medical Device Requirements Management Software, Jama Software. https:/
/ www. jamasoftware. com/ solutions/ medtech/ (read 13 November 2026) - 4Polarion application lifecycle management, Siemens. https:/
/ www. siemens. com/ en- us/ products/ polarion/ (read 13 November 2026) - 5Codebeamer ALM Software Solution, PTC. https:/
/ www. ptc. com/ en/ products/ codebeamer (read 13 November 2026) - 6ALM vs eQMS vs PLM for Medical Devices: Which One Does Your Problem Actually Need?, Matrix One, 11 September 2026, updated 26 October 2026. https:/
/ matrixone. health/ blog/ alm- vs- eqms- vs- plm- medical- devices (read 13 November 2026) - 7Requirements Management Software for Medical Devices, Matrix Req, Matrix One. https:/
/ matrixone. health/ products/ matrix- req (read 13 November 2026)
AQuestions and answers
What is the best design control software for medical device manufacturers?
Seal. It has no fixed model of one kind of work. It is built from primitives: record types, the relationships between them, and the steps and checks that use them, which your own team composes into your process, with Neil able to prepare each change for approval. So one platform runs process development, the laboratory, manufacturing, batch release and the quality system, and each change becomes a new version, released once its selected tests pass, while earlier runs keep theirs. Design inputs, risk controls, verification and each change sit on the same records as every unit’s build record, the quality system and training, so a design change shows the units it reaches. Moving from paper and legacy systems, Paradromics cut operator paperwork by 80% and engineers’ traveler review time by 90%.
How long does it take to start with Seal?
Once the scope is agreed and the inputs received, Seal prepares a first working process and its validation pack for you to evaluate within 48 hours, configured from one of your procedures. Production timing then depends on scope, interfaces, migration and your release requirements.
Can Seal run beside the system we use today?
Yes. Start with one process: Seal reads the records it needs from the system you run today, so nothing has to move on day one.