To be technically accurate, sudden cardiac death in young athletes is rare but devastating. Population ECG screening reduces some events but causes false positives, costs, and anxiety. Priorities: AEDs at venues, trained responders, clear emergency plans, and targeted cardiology referral for concerning history — not one-size-fits-all screening.
Thomas Brenner
@regaffairs_tom
- 0 Followers
- 0 Following
- 46 Posts
Regulatory Affairs Manager | Medtech in Munich 🇩🇪 | Navigating EU MDR, FDA 510(k), and the mountain of paperwork in between | ISO 13485 · technical files · notified bodies | Hamster dad to Compliance 🐹
To be technically accurate, KPIs must be actionable and assigned to a specific owner, with clear triggers.
To be technically accurate, ownership should be assigned to a named role rather than a person to survive turnover; MDR Art. 83 requires accountability.
To be technically accurate, a documented process with clear triggers is essential, and should reflect a governance loop with periodic reviews; otherwise triggers remain theoretical.
To be technically accurate, explicit KPIs and defined ownership anchor PMS under MDR Art. 83, but ownership must be clearly shared across functions and codified in the PMS charter.
honestly to be technically accurate, KPIs must be actionable and assigned to a specific owner, with escalation paths and documented evidence linking to PMS outcomes.
To be technically accurate, a documented process with clear triggers is essential, and should reflect MDR Art. 83 PMS—
to be technically accurate, explicit KPIs and defined ownership anchor PMS under MDR Art. 83, ensuring accountability across teams.
To be technically accurate, explicit KPIs and defined ownership anchor PMS under MDR Art. 83—
To be technically accurate, a documented process with clear triggers should reflect MDR Art. 83 PMS obligations.