Guide to Navigating FDA Regulatory Approval Process
In the U.S, the FDA regulates the sale of medical device products. To gain the FDA’s approval to sell a medical device, businesses must first present evidence of the products safety and effectiveness for its intended use. These regulatory approvals are just a piece of the product launch process but can be hard to manage. […]
Medical Device Engineering, Design and Build
Nortech Systems is a leader in the design, engineering and manufacture of medical device systems. Both our Engineering Design Center in Maple Grove, Minnesota and our Manufacturing Center of Excellence in Milaca, Minnesota are ISO 13485-certified. Our team of program managers and engineers partner with medical device companies to manage the entire lifecycle from initial […]
A Guide to Strategic Supplier Management in New Product Development
Developing a new product is a complex and dynamic process that requires the collaboration of multiple stakeholders, including engineers, designers, suppliers, and regulatory bodies. One key to successful new product development is managing suppliers effectively, ensuring they meet the required quality standards, cost targets, and delivery schedules. This guide will outline five phases of new […]
RoHS and REACH Compliance: Why Are They Important?
What are REACH and RoHS? RoHS (Restriction of Hazardous Substances) is a European Union (EU) directive restricting the use of hazardous substances in electronic products. It was introduced in 2003 to protect human health and the environment from potential harm caused by substances such as lead, mercury, cadmium, and hexavalent chromium. The directive aims to […]
Benefits of a Design for Supply Chain Methodology
If you have been involved in manufacturing anything in recent history, you have been there – you have customer orders waiting, your lines are down, and you are just learning now that your components won’t be available for weeks, or even months, because of supply chain issues. That low-cost custom part could now hold up […]
Supply Chain Risk Management Best Practices
When You Can’t Support Your Customers You may not be the doctor telling the patient that their medical tests and procedures have to be delayed because there aren’t enough supplies on hand. You may not be the operations officer watching your AOG (aircraft on the ground) hours rising out of control, leaving your troops immobilized […]
Program Management Is Key to Your Successful Product Launch
One of the key strategies to a successful on time and on budget product introduction is to partner with a firm that offers high-value program management services. As you evaluate possible partners, consider the project management methodology as well as the frequency and completeness of the communication with your team. Nortech’s program management team focuses […]
Factors to Consider When Assessing a Manufacturer’s Quality Management System
Why Is a Quality Management System so Important? A Quality Management System (QMS) is a formal system that documents processes and responsibilities for enforcing quality policies and objectives. A QMS helps support and direct an organization’s activities to meet customer and regulatory requirements and improve its overall performance. It covers aspects like documentation of the […]
Top Design for Manufacturability Considerations
The general engineering practice of designing products for manufacture is known as Design for Manufacturability (DFM). This technique is practiced across nearly every engineering discipline. This article details common design principles used to improve manufacturability, such as using a multi-functional team, standardizing parts, and minimizing over-constraints. Some of the expected benefits of incorporating these engineering […]
