Medtech startups with momentum don’t have a scaling problem.
They have a validation problem they only discover once they scale.
Assure Validation guides teams in redefining their validation approach, leading to manufacturing processes that hold up under audit pressure and are built to scale. That means less operational firefighting and more time to accelerate your business, from first commercial product to multi-market expansion.
New Product Launch Validation
There are so many manufacturing problems on existing product lines that no one has time to support the upcoming new product – and that puts your launch at risk.
If you don’t make the launch a priority, you’ll have essentially compromised your chance to set up a new product line that runs as smoothly at 10,000 units per month as it did at 100 units per month. Although initial production volume might be low, settling for “good enough” means you’re locking yourself into mediocre processes – and once the process is validated, there’s a limit to how much you can change without triggering re-validation – pain you’ll feel in lost time and engineering bandwidth.
Scope Includes:
- Manufacturing Readiness Assessment
- Process & Test Method Validation Strategy
- Validation Protocols - TMV, IQ, OQ, PQ
- Validation Execution Support & Statistical Analysis
- Validation Reports - TMV, IQ, OQ, PQ
Manufacturing Transfer & Capacity Expansion Validation
The second line that should have been a simple duplicate of your existing production line has turned out to be an underperformer, despite sharing the same manufacturing process.
It should be easy – nothing’s changed between the two lines. But any existing gaps in product and process documentation are guaranteed to show up during manufacturing transfer. The assumptions you make about equipment and process details will leave you wondering why your second line is struggling to keep up.
Scope Includes:
- Manufacturing Reproducibility Gap Assessment
- Equipment & Process Equivalency Assessment
- Equipment & Process Re-Validation - IQ/OQ/PQ
- Validation Execution Support & Statistical Analysis
Internal Audit Services - Manufacturing Focus
Something in your Quality System is broken, and you can’t ignore it – it shows up in a never-ending list of NCRs, CAPAs, and complaints – yet, despite your best efforts, you haven’t stopped the bleeding.
It makes sense that repeat production problems would make you take a deeper look at the production process. But repeat quality problems in manufacturing are a symptom of hidden QMS breakdowns – which explains why you can’t solve them by focusing all your attention on the production floor.
Scope Includes:
- Internal Audit of ISO 13485:2016 Production Sections
- Root Cause Analysis of QMS Breakdowns in Production
- Management Presentation of Findings and Opportunities for Improvement
- QMS Remediation Guidance
- CAPA Effectiveness Review
Standalone Services
For growing teams who need dedicated support with specific validation needs, Assure Validation offers the following individual services:
- Validation Protocol - IQ, OQ, PQ, or TMV
- • Detailed validation protocols for individual processes and/or test methods, enabling rapid execution and manufacturing readiness.
- Validation Report & Statistical Analysis - IQ, OQ, PQ, or TMV
- • Statistical analysis of results included in complete validation report for individual processes and/or test methods, enabling rapid troubleshooting and phase closure.
- Master Validation Plan
- • Create verification and validation plan based on process risks, tailored to your manufacturing efficiency goals and NPI timeline.
- Manufacturing Process FMEA
- • Develop PFMEA to guide verification and validation strategy based on process risks.
- Manufacturing Process Gap Assessment
- • Identify gaps in manufacturing process instructions that lead to non-standardized procedures, validation failures, NCRs, complaints, and audit exposure.
Serving Both Sides of the Atlantic
U.S. Companies with European Operations
U.S. medtech companies with suppliers or manufacturing operations in Europe often lack the on-site engineering support needed to diagnose process problems, execute validation work, and drive quality improvements at the source. Based in Rotterdam, Assure Validation provides the on-site presence your European operations need – going directly to the floor, writing the protocols, diagnosing root causes, and giving your team the same strategic validation support your U.S. operations receive remotely.
European Companies Expanding to the U.S. Market
European medtech companies expanding to the U.S. market need a validation partner who understands FDA expectations from the inside. The FDA’s recent transition from the QSR to the QMSR brings U.S. requirements into closer alignment with ISO 13485 – but the differences in how FDA enforces compliance require someone with direct U.S. industry experience. Assure Validation helps European companies build validation systems that satisfy both ISO 13485 and U.S. market requirements before a launch, not after a 483 finding.