Development and production of medical devices for cardiology and electrophysiology – from development through to approval.
livetec Ingenieurbüro GmbH
79539 Lörrach (Marie-Curie-Str. 8) · 79539 Lörrach (Wiesentalstr. 74, Götz+Moriz building)New on Amplifa
Range of Services and Competencies
livetec Ingenieurbüro GmbH, based in Lörrach, develops and produces medical devices for cardiology and electrophysiology. The portfolio includes temporary external pacemakers (Pace T10/T20), wireless long-term ECG Holter systems (liveECG), high-frequency ablation generators (RF liveGEN) with irrigation pump (RF liveCOOL) and remote control unit (RF liveCOMMANDER Remote), as well as low-energy laser therapy systems in cooperation with MKW Lasersystem GmbH. In addition to developing its own products, livetec carries out contract developments including regulatory approval for internationally active companies: analog and digital hardware and software development, EMC, microcontroller programming, automated test systems, as well as risk management and approval documentation according to EN 60601, MDR, FDA and other regulations. Production takes place in-house in Germany according to EN ISO 13485; the products are marketed worldwide under the company's own brand or as OEM/Private Label.
- Site
- Lörrach
- Processes
- Medical device development (development services, contract development incl. approvals), Analog circuit design and PCB layout, Digital circuit development (MSP430/ARM/STM32/STM8(L)/ATMEL/PIC), microcontroller programming, In-house production of medical devices (certified, process-oriented production according to, Automatic test systems (incl. radio-based systems), automated metrology for, Validation / approval / risk management / approval documentation (EN 60601, CE, FDA, CSA, UL,, Introduction into production up to series-production readiness, Specification creation, project planning, risk analysis, project management
- Materials
- Standards-compliant medical device development, Process-oriented medical device production, Electromagnetic compatibility and safety technologies, Microcontroller/embedded development, High-frequency generator technology, Radio applications for medical devices
- Certificates
- EN ISO 13485
- Industries
- Medical technology, Cardiology, Electrophysiology, Low-energy laser therapy (wound treatment, pain therapy)
- 01
Requirements/specification creation and risk analysis
- 02
Analog/digital hardware and software development
- 03
Automated metrology/test systems
- 04
In-house production (Made in Germany)
- 05
Validation and approval
- 06
Service and training via distributors
Development and Technologies
Standards-compliant medical device development
Development according to EN 60601 with CE, FDA, CSA, UL, CFDA/NMPA and MDR requirements.
Process-oriented medical device production
Certified, process-oriented production in-house.
Electromagnetic compatibility and safety technologies
Design of HF generators, EMC and safety technologies including battery charging and monitoring technology.
Microcontroller/embedded development
Digital circuit design (MSP430/ARM/STM32/STM8(L)/ATMEL/PIC) with real-time operating systems and GUI programming.
High-frequency generator technology
RF ablation generators for cardiac ablation and renal denervation.
Radio applications for medical devices
Radio technology, among others from development projects in the implant sector.
Locations
Lörrach (Marie-Curie-Str. 8)
DEHeadquarters
Lörrach (Wiesentalstr. 74)
DEBranch office and mailing address in the Götz+Moriz building
Products and Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Medical device development (development services, contract development incl. approvals)Engineering | – | – | – | – | – |
| Analog circuit design and PCB layoutEngineering | – | – | – | – | – |
| Digital circuit development (MSP430/ARM/STM32/STM8(L)/ATMEL/PIC), microcontroller programmingEngineering | – | – | – | – | – |
| In-house production of medical devices (certified, process-oriented production according toAssembly | – | – | – | – | – |
| Automatic test systems (incl. radio-based systems), automated metrology forTesting | – | – | – | – | – |
| Validation / approval / risk management / approval documentation (EN 60601, CE, FDA, CSA, UL,Engineering | – | – | – | – | – |
| Introduction into production up to series-production readinessAssembly | – | – | – | – | – |
| Specification creation, project planning, risk analysis, project managementEngineering | – | – | – | – | – |
Additional services
Reference customers
Quality and Approval
Production takes place in-house according to certified, process-oriented production in accordance with EN ISO 13485, with regular audits by official bodies and customers as well as automated test systems including radio-based systems. An in-house QA/RA/QS department handles validation, approval and safety.
| Evidence | Lörrach |
|---|---|
| EN ISO 13485 |