Medical Devices
ERP Medical Devices - Our software solution for Medical Device Companies
Product traceability, stringent quality requirements, and compliance with FDA, regulatory, and other requirements are just a few of the key factors that determine a company’s success in this field. This business relies on tightly controlled processes to produce high-quality products that meet stringent quality standards, while providing documentation to verify all procedures and withstand audits.
Technological progress sets the pace in the development and introduction of medical products. In addition, manufacturers must meet the cost pressure in the healthcare system and regulatory requirements.
Regulations for Medical Devices
- “Medical Device Regulation” (MDR)
- In-vitro Diagnostic Medical Device Regulation (IVDR)
- DIN EN ISO 13485 – Medical Devices
- ISO 9001 – Quality Management
- ISO 14971 – Risk Management of Medical Devices
- etc.
- 21 CFR Part 11 – Electronic Records; Electronic Signature
- etc.
The high level of responsibility that a medical device company bears regarding product safety and documentation requires a certain structure. In addition to the specific requirements, warehouse and inventory management, forecasting, logistics, shipping, and customer service must also be managed. With a powerful ERP solution, this is not a problem.
Performance expectations for ERP medical device software
In the medical device industry, core processes are often executed manually or in disconnected systems. This leads to sources of error and considerable additional work. The use of modern ERP systems opens opportunities for process optimization: from product development and manufacturing to the service of medical products.
We at b4dynamics have worked on Software expanding the core platform of Microsoft Dynamics 365 and now additionally offer improved functions for the medical device sector for:
- Digital Document Management
- Regulatory Compliant Electronic Signature
- Digital platform for software implementation and validation
- Electronic Device Record (EDHR)
- Testing platform for automated software process testing
- Sampling plan according to DIN/ISO 2859
Business Process
Quality Management
Supply Chain
Production
Focus
- Complaint Management
- Corrective and Preventive Action (CAPA)
- Non-Conformance (NCM) & Out-of-Specification (OOSR)
- Test orders and sample management according to ISO 2859
- Supplier audits and supplier management
- Gauge management and calibration
- Product recalls
- Delivery area constraint matrix
- CMO / 3PL Management
- Approved suppliers
- Test orders and sample management
- Electronic Device History Record (EDHR)
- Advanced data mapping
- Error codes in production
- Splitting of production
- Reworking during and after production
- Unique Device Identification (GUIDID)
- FDA compliant label printing
Business Process: Quality Management
- Complaint Management
- Corrective and Preventive Action (CAPA)
- Non-Conformance (NCM) & Out-of-Specification (OOSR)
- Test orders and sample management according to ISO 2859
- Supplier audits and supplier management
- Gauge management and calibration
- Product recalls
Business Process: Supply Chain
- Delivery area constraint matrix
- CMO / 3PL Management
- Approved suppliers
- Test orders and sample management
Business Process: Productiion
- Electronic Device History Record (EDHR)
- Advanced data mapping
- Error codes in production
- Splitting of production
- Reworking during and after production
- Unique Device Identification (GUIDID)
- FDA compliant label printing
