Medical Device & Products Industry Overview
This industry is comprised of establishments primarily engaged in manufacturing medical equipment and supplies. Examples of products made by companies in this industry include:
- Laboratory apparatus and furniture
- Surgical and medical instruments
- Surgical appliances and supplies
- Dental equipment and supplies
- Orthodontic goods
- Dentures
- Orthodontic appliances
A medical ERP system must help the company gain a detailed understanding of the customer’s needs and their experiences, both of which are essential to success, and a source of competitive advantage if executed precisely.
Innovation can be a risky, complicated topic in the field of medical devices and products. Challenges include long development cycles and rigid regulations, which place a premium on building products correctly the first time.
Related Industries
The following industries function in tandem with medical devices and products:
- Surgical instruments
- Measuring and controlling devices
- Dental equipment
- Medical instruments
Sub-Industries
Sub-industries within medical devices and products include:
- Surgical and medical instruments
- Rifles, for propelling hypodermics into animals
- Ophthalmic instruments and apparatus
- Surgical instruments and apparatus
- Muscle exercise apparatus, ophthalmic
Critical Requirements of a Medical ERP System
In an effort to ensure premium quality assurance practices used for the design of medical devices remain consistent with worldwide quality system requirements, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. An important component of the revision is the addition of design controls.
Per the FDA, design controls must apply to a wide variety of devices. Contrary to previous practices, this regulation states manufacturers must use the development and implementation of design controls in order to gain a framework of the client.
When evaluating vendors, you should look for experience in achieving FDA certification.
These are a few of the unique challenges and critical requirements medical device manufacturers need, which should be offered by state-of-the-art medical ERP software:
- Customer Relationship Management (CRM Software)
- Quoting and Estimating
- Order Processing
- Product Data Management (PDM)
- Product Lifecycle Management Software (PLM)
- Document Management
- Engineering Change Management
- Forecasting and Demand Planning
- Lean Manufacturing
- Supply Chain Management
- Serial Numbers
- Lot Numbers
- Recall Management
- Advanced Manufacturing Planning
- Quality
- Warehouse Management Software (WMS)
- Plant Equipment
- Cost Accounting
