Improving lives through medical technology
Your Trusted Partner in Medical Device Engineering
Medical Device Industry is going through a major shift in terms of technology advancement with the adoption of Software Technologies in the devices and frequent changes in global regulations and international standards.
We, at Saraca Solutions, have always been advancing along with industry trends and have evolved with resolving the challenges being faced by the industry.
What We Do
We bring a unique value to our medical device customers with integrated capabilities in Product engineering as well as Quality Assurance, Regulatory & Clinical Affairs. Our engineering capabilities span across mechanical design, electronics design & embedded software with an experience across several therapeutic areas.
Medical Device Segments
Cardiovascular Devices
Ear, Nose, and Throat Devices
Neurological Devices
Ophthalmic Devices
Orthopaedic Devices
Radiology Devices
Maxillofacial Devices
Sterile & non-sterile devices
In-vitro Diagnostic Devices
Our Service Offerings
Mechanical Design
- Design of implants, instruments and electro-mechanical equipment
- Design of Orthopaedic, Cardiovascular, In-vitro diagnostic and automated medical systems
- 3D part and assembly modelling
- 2D drawing development
- GD&T and tolerance stack-up
- Structural, Thermal and CFD analysis for Medical Devices
- Prototyping
Electronics Design
- Electronics design for medical device applications
- Analog and digital design
- Microcontroller and Microprocessor based design
- SOC/SOM, IOT & Sensor based medical device design
- USB, Ethernet, CAN, Bluetooth, Wi-fi, UART, I2C
- Multilayer PCB design & development
- RoHS, REACH and EMI/EMC Compliance support
- Prototyping
Embedded Software
- MCU/MPU: Renesas, NXP, STM, Infineon, Nvidia, Cypress, Qualcomm, Intel
- OS: MICROSAR, Linux, QNX, OSEK, VX works, FreeRTOS, Green Hills
- Protocols: J1939, CAN-FD, LIN, UDS, MOST, Flexray, BLE, Ethernet, Automotive Ethernet, MODBUS, LVDS
- Languages: Embedded C, C++, Python, JAVA, Dart
- Standards: ISO 62304, IATF 16949, ASPICE, MISRA-C
- Driver Development: I/O, CAN, LIN, BLE, Crypto drivers, NVM, DMA, Sensors – Temperature, Pressure, Level, Proximity, J1939, Ethernet
Quality Assurance
- Adapt or build a new quality management system to comply with ISO 13485, FDA 21 CFR 820, and EU MDR
- Risk Management per ISO 14971
- Gap analysis & Remediation of DHF, Technical File and Risk Management File
- Compliance to ISO 62304, IEC 60601 for Medical Software Development and Electrical safety
- Post-Market Quality support – NC, CAPA, Complaint handling etc.
- Verification & Validation support
- Manufacturing Process development and design transfer support
- Supplier and Internal Audits
Clinical Evaluation Report (CER)
- Clinical Evaluation Plan
- Literature Search
- Clinical background, Current knowledge and State of the Art
- Integrating PMS data
- Integrating Risk management data
- Benefit risk analysis
- Compilation and conclusion of CER
- Support until document approval by notified body
Performance Evaluation Report (PER)
- Performance Evaluation Plan (PEP)
- Performance Evaluation Report (PER)
- Scientific Validity Report (SVR)
- Analytical Performance Report (APR)
- Clinical Performance Report (CPR)
- Tech File Submission and Review
- IVDR Readiness Audits and Mock Audits
- Gap Assessments in the existing PER
Post Market Surveillance
- Complaint Handling: Complaint Review, Complaint Investigation, Determination of CAPA if needed, Root-Cause Analysis, Response to Complaint, Complaint Closure
- Adverse Event Reporting: Vigilance Search & Reporting, Trend Reporting, Field safety corrective actions, Field safety notice
- CAPA: Problem Identification, Root Cause Analysis, Corrective and Preventive Action Plan, Verification of Implementation, Closure
Software Quality Assurance
- Quality support for Software (NPD) DHF documentation per IEC 62304
- Software Risk Assessment
- Quality support for Software V&V
- Documentation preparation and review
- Quality support throughout phase gate process
Regulatory Affairs Consulting
- Global Regulatory assessment, planning, and strategy
- Traditional and special 510(k), Pre-Market Approval (PMA) preparation and submission
- Medical Device Reporting and Vigilance Reporting
- Labelling and Instructions for Use
- Remediation resulting in audits or inspections
EU MDR & EU IVDR
- MDD to MDR Gap Assessment and transition
- Device Classification per EU MDR
- Development & remediation of STED
- GSPR Compliance
- Clinical Evaluation Report (CER)
- Post Market Clinical Follow-up (PMCF)
- Periodic Safety Update Report (PSUR)
- Summary of Safety and Clinical Performance (SSCP)
- Vigilance search & reporting
EU IVDR
- IVDD to IVDR Gap Assessment and transition
- Development & remediation of STED
- GSPR Compliance
- Scientific Validity Reports
- Clinical Performance Reports
- Performance Evaluation Reports (PERs)
- Post Market Performance Follow up (PMPF)
- Post Market Surveillance (PMS) Protocols and Reports
- Vigilance Reporting as per Article 82 of the IVDR
- Package insert/IFU
