CER, Clinical Evaluation Reports

Productized clinical evaluation reports for medical devices

What it is

Partner-led offering: Vimal owns the product and customer relationship; Infinitra is the tech delivery partner.

Make money for the customer

  1. Each quarter of accelerated entry = $2.5M pulled-forward revenue (for $10M ARR device)
  2. Reduces device CEO time on regulatory back-and-forth
  3. Higher submission quality = lower revision risk

Save money for the customer

  1. Reduces consulting and regulatory-writer labor cost
  2. Reduces submission revision cycles (each revision = 2-4 months delay)

Customer proofs

Partner-owned (Vimal)

AWS service surface

TBD (regulatory-focused, less AWS-centric)

AWS strategic angle

Limited AWS strategic angle (regulatory-focused). May fold into Healthcare Competency as supporting evidence.