Compliance Acceleration Program

A 90-day program
to get you audit-ready.

Audit-ready means every SAHPRA-Ready Mode criterion is green and our mock inspection is closed. It is our readiness standard, not a SAHPRA or certification-body decision, and we cannot guarantee any inspection or certification outcome.

Done-for-you SAHPRA + ISO 13485 compliance for SA medical device companies that need this fixed, not explained. Platform + regulatory advisory + implementation in one program.

Book a 30-min discovery call →Just want the software? See SaaS pricing
90-day plan, scope in writingZAR billing — no forexBuilt in South Africa

Who this is for

✓ This is right for you if

  • ●You're applying for a SAHPRA establishment licence and need to be ready to submit
  • ●You're a director and want a clear, evidenced view of your compliance position, not just paperwork filed
  • ●You don't have an in-house quality team — or yours is overloaded
  • ●You've failed an audit and need to get back into compliance fast
  • ●You need the QMS to win a tender or close an export deal

✗ This is the wrong fit if

  • ●You already have a working QMS and just want a tracking tool — go to SaaS pricing
  • ●You want to build the QMS yourself and learn the regulations along the way
  • ●You can't commit a 4-hour-per-week internal champion to work with us
  • ●You're shopping on price alone — this isn't the cheapest option

What's in the program

Software + regulatory advisory + done-for-you implementation. One program, one bill, one outcome.

01

Platform

Full ISO-13485 Compliance OS Scale tier (unlimited users) for the duration of the program. After the program, platform access continues within your monthly fee. Everything: ISO 13485 modules, AI gap analysis, audit pack, Director Risk Dashboard, SAHPRA-Ready Mode.

02

Regulatory advisory

Direct working sessions with our regulatory advisor. Weekly 60-minute call for the first 8 weeks. SAHPRA submission strategy, gap remediation prioritisation, document review.

03

Done-for-you build

We build your QMS in the platform with you, not for you. Document control, CAPAs, internal audit programme, management review cycle, training matrix, risk register — all live in the system, all linked to ISO clauses.

Eight weeks of build. A 90-day commitment.

The program plan runs eight weeks. The 90-day commitment leaves room to close what the mock inspection finds — and if you’re not audit-ready by day 90, we keep working at our cost — on the scope we agreed, against the readiness criteria we record at kick-off, for up to a further 60 days. The conditions are in our terms (§4.3).

Week

1

Discovery + scoping

We map your current state, your products, your existing documentation, and your SAHPRA submission target date. Output: a written program plan with milestones.

Week

2 – 3

QMS spine + document control

Stand up document control with your existing SOPs and our pre-built ISO 13485 starter library. Quality manual, document numbering, version control workflow live.

Week

4 – 5

Operational SOPs + risk register

CAPA, internal audit, management review, training matrix, supplier control, calibration. Risk file (ISO 14971-aligned) populated from your existing product data.

Week

6 – 7

Mock inspection + remediation

Our regulatory advisor runs a mock inspection of your QMS against SAHPRA requirements. Every gap goes onto the platform's CAPA tracker with an owner and a due date. We work each one with you.

Week

8

SAHPRA-Ready verification

All 12 SAHPRA-Ready Mode criteria green. Audit Pack v2 generated and reviewed. Director Risk Dashboard signed off by your CEO. Program complete.

Pricing

Two implementation tiers. Final scope confirmed in the discovery call once we understand product complexity, sites, and timeline.

Standard

Single-product manufacturer or distributor.

One-time setup

R120,000 – R250,000

Then monthly

R15,000 – R30,000 / mo

Includes platform + ongoing advisory hours.

  • Full platform access (Scale tier, unlimited users)
  • Weekly 60-min advisory call (8 weeks)
  • Pre-built ISO 13485 SOP starter library
  • Up to 25 controlled documents migrated / drafted
  • Internal audit programme set up
  • SAHPRA submission readiness verification
  • 90-day readiness commitment

Enterprise

Multi-product, multi-site, contract manufacturers, exporters.

One-time setup

R300,000 – R800,000

Then monthly

R30,000 – R80,000 / mo

Includes platform, advisory days and on-site days, as your statement of work sets out.

  • Everything in Standard, plus:
  • Regulatory advisory days each month, set in your statement of work
  • Multi-site QMS scoping
  • Up to 100 controlled documents migrated / drafted
  • Integrations (LIMS, ERP), scoped and quoted separately
  • Direct line to founder + quarterly board reviews
  • Phase 2 international regulator strategy session
  • 90-day readiness commitment

We are not registered for VAT, so no VAT is added to these prices.

The 90-day readiness commitment — fine print

We commit to having your organisation audit-ready (verified via our SAHPRA-Ready Mode checklist + a mock inspection against SAHPRA requirements by our regulatory advisor) within 90 calendar days of program kick-off. If we're not, we keep working at our cost until you are. This commitment is contingent on you committing one internal champion for at least 4 hours per week and providing existing documentation within the first 7 days. Final terms confirmed in the program agreement.

Book a 30-minute discovery call

A short call about the program. We'll ask 10 questions about your current state and tell you whether it is the right fit. If it isn't, we'll point you to the platform plans instead.

Pick a time

Replies within one business day. We're based in Cape Town.