Accepting 10 MedTech organizations

MedTech compliance at the speed of delivery

Stop turning every release into a compliance project. SmoothGlue helps standardize controls, traceability, evidence, and approvals so governance becomes part of delivery, not bolted on after.

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The MedTech Problem
From compliance bottleneck to audit-ready on every release.
The hard part isn’t adding more controls. It is making governance, traceability, and evidence part of the delivery flow instead of a parallel process.
60-70%

of platform engineering time is lost testing, deployments, security, compliance

Harness
Press and news release
View source
6-18mo

510(k) submission delay due to insufficient automation in regulatory operations

Veeva
2025 MedTech Regulatory Affairs Benchmark
View source
67%

of MedTech orgs unable to generate audit evidence automatically

Greenlight Guru
2024 State of the MedTech Industry Report
View source
What’s actually happening
  • Requirements are open to interpretation

    Teams spend cycles aligning instead of shipping

  • Evidence gets assembled at the end

    Validation turns into a last-minute scramble

  • Approvals live in emails and spreadsheets

    Releases stall waiting for sign-off

  • No environment parity

    Cannot prove prod meets the same FDA/HIPAA controls as dev

  • Compliance sits outside delivery

    Every change introduces friction

What changes with SmoothGlue
  • Requirements, tests, and releases stay connected

    Traceability is always current, not assembled after

  • Evidence is captured as work happens

    Audit prep stops becoming a last-minute fire drill

  • Approvals are built into the flow

    Approvals move inside the release path, so blockers are visible instead of buried

  • Environment parity is continuously checked and easier to prove

    Consistent compliance posture from dev through production

  • Governance is enforced by default

    Compliance is built in, nothing slips through

The MedTech Platform

Two layers for MedTech. Complete coverage.

Whether you are building the pipeline or running the workload, governance and compliance are embedded, not bolted on.

SmoothGlue Build

Secure development and delivery

Opinionated CI/CD workflows, artifact handling, SBOM generation, policy checks, and traceability from commit through release.

  • Policy-as-code enforcement in pipelines
  • SBOM generation on every build
  • Automated security scanning and hash verification
  • Standardized templates across teams
  • Traceable path from commit to test to release
SmoothGlue Run

Governed production operations

Deploy, monitor, and manage workloads with role-based access, audit logging, compliance visibility, and drift-aware operations.

  • Guaranteed environment parity from dev to prod
  • Continuous compliance monitoring dashboards
  • Policy-based remediation workflows
  • Role-based access and audit logging
  • Zero-trust-aligned runtime controls
Limited Engagement

We're working with 10 MedTech organizations to operationalize compliance-first delivery.

We're selecting a small group of platform-forward MedTech organizations to experience what compliance at the speed of delivery actually looks like and shape the product alongside us.

Step 01

Strategy Session

30-min conversation. We confirm fit and talk through your delivery and compliance landscape.

Step 02

Platform Readiness Briefing

A guided review of your compliance automation maturity across 5 pillars. You keep the insights regardless.

Complimentary
Step 03

Guided Proof of Concept

See SmoothGlue running against your actual environment. Real policies, real pipelines, real compliance.

Step 04

Production Launch

We roll out alongside your team with no disruption to ongoing delivery. Practical timeline, practical plan.

Platform Readiness Briefing

See exactly where your MedTech compliance time is really going.

A consultative review, not an audit. We map your current state across 5 pillars and give you an honest benchmark of where automation closes the gap.

01

Evidence Generation

Manual vs. automated audit trail. Still using spreadsheets and screenshots?

02

Environment Parity

Can you prove prod matches dev/staging right now for FDA and HIPAA?

03

Supply Chain Integrity

SBOMs, artifact provenance, container scanning. What is running in prod?

04

Deployment Velocity

DORA metrics overlaid with compliance gates. Commit to compliant release time?

05

Incident Response

Critical vuln drops. Can you push a compliant fix in hours or months?

You walk away with actionable direction whether or not SmoothGlue is the right fit. No strings.

Engineered for Regulated MedTech Environments

Built to support the evidence, controls, and workflows regulated teams need.

HIPAA
Supports HIPAA-aligned security and audit workflows
FDA 21 CFR
Supports Part 11-relevant electronic record and approval controls
IEC 62304
Supports traceable software lifecycle delivery
ISO 13485
Supports ISO 13485-aligned QMS evidence workflows
SOC 2
Designed to support SOC 2 control evidence
ISO 27001
Built for ISO 27001-aligned security governance
Built For

MedTech Platform and Cloud Leadership

This is for teams already delivering in regulated environments and tired of rebuilding compliance on every release.

VP Platform Engineering
Director of DevSecOps
Head of Platform Engineering
VP Engineering Infrastructure
Director of Cloud Engineering
Head of Internal Dev Platform
The teams in MedTech that move fastest won’t just add cloud tooling. They’ll operationalize governance earlier.
Common Questions
FAQs
No. SmoothGlue is not rip-and-replace. If you already have pipelines you have invested in, SmoothGlue Run integrates with your existing artifacts and deploys them into a governed, compliant runtime. You keep what works and we fill the gaps.
The opposite. SmoothGlue eliminates manual handoffs, duplicated effort, and last-minute compliance scrambles. Governance becomes part of delivery, not something layered on top.
Yes. Traceability is built into the delivery flow. Requirements, tests, and releases stay connected automatically, so the audit trail is always current and not assembled at the end.
Security controls and SBOM generation are embedded in the build pipeline, not added after. Meet vulnerability and provenance expectations without manual steps or late-stage rework.
Built for regulated MedTech delivery: HIPAA, FDA 21 CFR Part 11, IEC 62304, ISO 13485, SOC 2, ISO 27001, HITRUST. In the strategy session, we map directly to your specific requirements.
A 2-hour guided conversation, not a pentest and not an audit. We walk through your toolchain, compliance workflows, and deployment process across 5 pillars. A week later, you get a visual scorecard, gap analysis, and prioritized roadmap that is yours to keep regardless of next steps.
Ready to Make MedTech Compliance Part of How You Deliver?
We're accepting 10 MedTech organizations for our guided engagement, including a complimentary Platform Readiness Briefing.
  • 30-min strategy session to confirm fit
  • Limited-fit readiness conversation
  • Actionable insights you keep regardless
  • No generic sales pitch. No spam.
Personal data

BrainGu is committed to protecting and respecting your privacy, and we'll only use your personal information to administer your account and to provide the products and services you requested from us.

In order to provide you the content requested, we need to store and process data entered on this form. If you consent to us storing your personal data for this purpose, please tick the checkbox above.