In april 2025 we proudly launched our new strategic recruitment business in close collaboration with Agnes Munter AB. She brings a solid experience to MMC and ensures that our clients recruit the right skills to the right positions.

Thursday the 16 january 2025 two new skilled partners joind the team. Skillwell and Life Science Byrån. A very competent contribution in product and process development.

Q4 2024 - forward

Class lll Catheter Development

We will assume end-to-end Project Management for a Class lll catheter program, covering all aspects as Product Definition & Feasibility, Design Control, Risk Manegement, Process Developmen & Controls, Suplier onboarding, and V&V strategy. More updates to follow.

Mar 2025  |  Design Control

Design Requirement Specification (DRS) Delivered first revision
MMC has developed and issued a Design Requirements Specification (DRS) for a Class III medical device, translating user needs, risk assessments, and EU MDR / FDA QSR mandates into precise engineering requirements.

Mar 2025  | Process Control

Correlation Study for replacing Measurement System
We have launched a statistical correlation study to align two independent measurement systems that inspect the same critical dimension on a single component. Results will optimize in‑process controls and shorten release cycles.

Apr 2025  |  Quality & Compliance

ISO 14971 Risk File initiated and partially completed for Class III Device
MMC and its cross‑functional team have partially finalized the ISO 14971 risk‑management dossier for an invasive Class III medical device. The package includes:
Device‑safety characterization, Hazard analysis & device‑risk assessment and FMEA & risk/benefit justification, This work positions the client for a streamlined regulatory submission.

May 2025  |  Regulatory Readiness

ISO 13485 & FDA QSR Audit Scheduled for June
MMC will perform a full‑scope quality‑system audit at a U.S. facility in June 2025, verifying complete compliance with ISO 13485:2016 and FDA 21 CFR 820 and confirming that the QMS is inspection‑ready.

Ongoing  |  Process equipment development

Automated Needle‑Grinding System Enters Final Development Phase
We are spearheading the development of a fully automated needle‑grinding machine with integrated vision‑guided process control. The project is on track for completion in June 2025 and will deliver next‑generation precision and productivity for a scale up needle manufacturing.