ISHA BIOMECH PRIVATE LIMITED

End-to-end manufacturing of electrotherapeutic and electromedical devices aligned with NIC 26600. Services include precision PCB assembly, ISO-compliant cleanroom fabrication, component sourcing, and final system integration for therapeutic and diagnostic equipment used in hospitals and clinics across the Maharashtra National Capital Region.

Capable of small-to-medium batch production; regulatory documentation support; factory acceptance testing

Design and production of irradiation system subsystems such as control electronics, high-voltage modules, and thermal management assemblies. Engineering processes emphasize electromagnetic compatibility, safety interlocks, and repeatable manufacturing tolerances for reliable operation in medical and industrial environments.

Prototyping to production runs; EMI/EMC testing; traceable BOMs and lot control

OEM partnerships for custom electrotherapy products, including contract design for electrodes, power delivery circuits, embedded firmware, and user interface housings. Focused on configurable platforms to support device variants, streamlined regulatory registration in India, and scalable production pathways for market entry.

Design for manufacture, rapid validation cycles, and transfer to scale-up

End-to-end contract manufacturing for irradiation, electromedical and electrotherapeutic devices including PCB assembly, mechanical integration, enclosure fabrication, final assembly, and manufacturing documentation aligned with NIC code 26600 and Section C requirements.

Scalable volumes from pilot batches to full production runs

Regulatory support covering device classification, technical file preparation, CE/ISO alignment, and batch release protocols. In-house quality assurance offers process validation, risk management, and traceability necessary for medical device audits and clinical deployment.

Supports regulatory filings and audit readiness across the product lifecycle

Scheduled calibration, preventive maintenance, and rapid field service for electromedical equipment within Maharashtra NCR. Service offerings include certified technicians, spare-parts logistics, and software updates to maintain device efficacy and safety in clinical environments.

SLA options with same-day or next-business-day response for critical care customers