Sparta Care / Advisory

Regulatory strategy
and operational execution,
from scoping to certification.

Regulatory scope to clarify, Technical File progressing in fits and starts, product roadmap slowing down. Sparta Care manages the regulatory dossier end to end, from initial scoping to certification.

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Our services.

Regulatory strategy and operational execution, from scoping to certification.

Regulatory strategy

Classification, gap analysis, MDR 2017/745 and IVDR 2017/746 roadmap.

CE marking

Technical File, ISO 13485 Quality Management System, Notified Body submission management.

eQMS implementation

Setup and maintenance of a Quality Management System within your tools, for simplified adoption by your teams.

Internal audit

MDR 2017/745 and ISO 13485 compliant internal audits, conducted by GMED-certified auditors and digital medical device experts.

ANS compliance

Gap analysis and requirements assessment to achieve ANS compliance.

Our approach.

A dedicated team for your dossier, a former manufacturer's perspective, regulatory expertise at the right level, and structured project management. This combination reduces total CE marking duration.

01

Pragmatism

  • Former software medical device manufacturers.
  • Regulatory decisions also viewed through a business and product roadmap lens.
  • Processes calibrated to the organization's actual maturity.
02

Regulatory expertise

  • MDR 2017/745, IVDR 2017/746, ISO 13485, IEC 62304, ISO 14971.
  • GMED-certified internal auditors.
  • Active monitoring of the AI Act and ANS developments.
03

Project management

  • Reverse planning through to Notified Body submission.
  • Milestone tracking, anticipation of blockers.
  • Managing the relationship with the Notified Body.
6 months saved

Time saved on Technical File preparation thanks to our approach and project roadmap.

They trust us. 40 teams supported.

Regulatory milestones

The CE marking
journey.

Going from software to a certified medical device follows a sequence of structuring steps: product scoping, regulatory strategy, quality system, technical file, and certification.

Step 01

Product and tech stack analysis

Presentation of the device, its features, and the technologies used. Understanding of technical choices, clinical objectives, and market access goals.

Step 02

Regulatory strategy definition

Identification of applicable frameworks (MDR 2017/745, IVDR 2017/746, ISO 13485, IEC 62304, etc.) and development of a regulatory trajectory aligned with the product roadmap and business priorities.

Step 03

Quality Management System setup

Design of a quality system compliant with ISO 13485 and MDR 2017/745, proportionate to the organization's size and maturity, ensuring control of key processes. Harmonization with the existing ISMS. Support for QMS adoption. Internal audit and improvement plan.

Step 04

Technical File development

Support in deploying the various phases of the technical roadmap. IEC 62304 compliant documentation drafting. Clinical evaluation coordination.

Step 05

Certification

Submission to a Notified Body, interaction management, and audit support.

Working with Sparta Care was a great experience. The engagement was clear and fast. The team demonstrated a highly appreciated pragmatic mindset, outstanding availability and speed, and provided real reassurance throughout. Having them write documentation on our behalf also truly made the difference for us.

Tanel Petelot · CEO · Emobot
CTA Component — Sparta Care
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30 minutes to scope your needs.

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Certifications & partnerships
GMED certified
for QMS internal audit
BPI France
experts