medical devices Archives - Means Engineering, Inc.

Recent Changes to IEC 60601-1 Impact Medical Device Manufacturers

December 4, 2020 By meiadmin

When creating devices for the medical industry, it’s crucial that manufacturers take care to ensure the quality, consistency, and reliability of every part produced. This isn’t just important for consumer satisfaction, it’s crucial for the health and safety of those that use these important devices.

Medical devices are regulated by the Food and Drug Administration (FDA). In order to prove compliance, medical device manufacturers must meet the standards for the safety and essential performance of medical electrical equipment.

The internationally recognized standard, IEC 60601, was first published in 1977. Since that time, the standard has been updated and restructured several times. The most recent update to IEC 60601-1 was published earlier this year and includes several changes and clarifications. It’s important that medical device manufacturers learn and understand these changes to ensure compliance.

The most recent amendment, A2:2019, will mark the standard for medical devices for the next few years. The next change is not expected until 2024.

Important Changes to IEC 60601-1

While some of the changes to IEC 60601-1 seem minor, they could result in previously certified devices not meeting the new requirements for compliance. It’s crucial that medical device manufacturers take some time to make themselves familiar with A2:2019.

IEC 60601-1 A2:2019, also known as Version 3.2, includes 78 changes. The most important changes are listed below.

IEC 60601-1 A2:2019 updates out-of-date references to ISO 14971 and IEC 62304
Amendment 2 includes important changes that align IEC 60950-1: A2 and IEC 62368-1 in regards to safety requirements for audio/video, information, and communications technology
A2:2019 includes error rectification and clarifications
The Amendment includes changes affecting the design and layout of medical devices
The Amendment also includes changes to standards for labelling, electrical hazards, mechanical hazards, thermal hazards, hazardous situations and fault conditions, and ME systems.

It’s important to note that these changes apply to both manufacturers and those responsible for testing medical devices and medical device components. Testers can only accept components that comply with IEC 60950-1 until December 20^th, 2020. After this date, in stock medical devices and components can no longer be used.

Medical Device Contract Manufacturing Services

Working with an experienced contract manufacturer can help ensure compliance with FDA requirements. An experienced CM has the tools, experience, and technology needed to keep up with changing regulations.

Means Engineering offers contract manufacturing services to OEMs and organizations in the medical industry. Please contact us for information about our services.

Medical Device Creation – Ensuring a Successful Contract Manufacturing Relationship

November 20, 2020 By meiadmin

Contract manufacturing enables organizations to produce products without the large expense of machinery and technology or the operating costs associated with manufacturing. While contract manufacturing offers numerous benefits to companies across a wide range of industries, there are significant benefits for the medical equipment and device segment.

Strict requirements and the need for machinery capable of creating precision-dependent products often creates a barrier for organizations wishing to enter the medical device industry. These same factors cause many OEMs to leave the market as well. Organizations could benefit from utilizing the help of an experienced medical device contract manufacturer.

Hiring a contract manufacturer allows OEMs to spend less capital, hire fewer employees, spend less time and effort on quality control, and eliminate purchasing hassles. The contract manufacturer handles procurement, production, and testing, allowing the OEM to focus on other important aspects of their business.

Organizations wishing to hire a contract manufacturer should consider it as they would any other long-term business relationship. Before selecting a CM, it’s important to gather as much information as possible.

Selecting a Contract Manufacturer

OEMs should take care to ensure they fully understand the capabilities, strengths, weaknesses, and experience of the contract manufacturer they choose. It’s highly suggested that OEMs develop a list of questions prior to contacting and interviewing each CM. It might also be beneficial for the OEM to contact some of the CM’s customers for feedback.

Process Development

After selecting a contract manufacturer, the development process begins. If this is an existing product being transferred from the OEM, all existing work instructions and raw material sources get shared with the CM at this point. During a series of “knowledge transfer” meetings, the OEM and their staff provide as much information as possible about the manufacturing process. These meetings shouldn’t just include engineers and operators, assembly workers with experience creating the part should be involved as well.

For new products, the contract manufacturer will need to develop the manufacturing process and supply chain. However, it’s still important for the OEM to provide input and knowledge as necessary.

Training & Process Qualification

Once the process is defined, operator training and qualifications begin. Regardless of the type of product, there are standards and optimum processes to adhere to. This is especially true when producing medical devices. These devices face some of the strictest quality standards.

Pilot Builds

The pilot build allows OEMs and contract manufacturers to locate areas that could benefit from improvement. This is the stage when the OEM or CM makes adjustments to the work flows and/or the work instructions.

Entering the Production Phase

Following the pilot build, the CM begins production of the product. It’s crucial that OEMs provide an accurate demand forecast at this point. This helps the CM determine raw material procurement schedules and reorder points.

Means Engineering provides contract manufacturing services for the medical device industry. Please contact us for details.

How Start-Ups & Entrepreneurs Utilize Contract Manufacturing

November 13, 2020 By meiadmin

Entrepreneurs face many challenges when starting a business. In addition to figuring out how to properly market and brand their business, they must also determine how to bring new products to market. Obtaining office space and hiring and training marketing personnel and office management takes up a significant portion of a start-up’s budget, leaving very little to produce prototypes. Unfortunately, it’s not likely that a start-up will receive funding without a tangible product that investors can see and touch.

Outsourcing makes it possible for entrepreneurs and start-ups to produce products without acquiring additional space, equipment, machinery, or people. Utilizing a contract manufacturer not only saves money, it eliminates many of the issues commonly faced by new businesses.

Creating High Quality Products

No one wants to purchase an inferior product. Manufacturers must ensure the quality and consistency of every product produced.

Contract manufacturers often have years of experience. They provide a second set of eyes for design plans. When utilized during the design phase, contract manufacturers help spot areas that could benefit from improvement. This helps avoid costly repairs and recalls, saving the organization time and money and helping ensure customer satisfaction.

Ensuring Compliance with Industry Regulations

It’s important that manufacturers remain compliant with the safety and environmental regulations of their industry. Experienced contract manufacturers, like Means Engineering, carry multiple industry certifications to ensure compliance with internationally recognized standards for both safety and quality.

Choosing a Contract Manufacturer

When selecting a contract manufacturer to work with, it’s important to locate an established organization with experience working with multiple industries. Even if the organization does not plan to move into new markets, knowing this option is available can make a big difference if anything changes in the future.

For organizations that plan to obtain their own manufacturing equipment, building a good relationship with a contract manufacturer ensures the continuous flow of products. Contract manufacturers often help businesses fulfill orders during periods of high demand.

Means Engineering provides comprehensive contract manufacturing services for businesses across a wide range of industries. Please contact us for more information about our services.

The Importance of ISO 13485 Certification

August 28, 2020 By meiadmin

Organizations responsible for the design and production of medical devices need to understand the strict standards and requirements of government officials. Used for a wide range of applications, medical devices may mean the difference between life and death for those that rely on them. In the United States, medical devices are regulated by the FDA and organizations must receive ISO 13485 certification prior to their design or assembly.

About ISO 13485

ISO 13485:2016 aligns with ISO 9001:2008. It’s important to note that this version of ISO 9001 does not include the same Annex L of the 2015 version. ISO 13485 includes several safety requirements to ensure the quality and reliability of devices created for the medical industry.

Although several countries have their own set of regulations regarding medical device design and creation, ISO 13485 is the main Quality Management System (QMS) standard for medical devices. While organizations in the United States must meet both ISO 13485 and FDA requirements, the FDA plans to eventually harmonize the two.

Despite what many people believe, ISO 13485 is aimed at ensuring high quality products. It is not a standard for products. Instead, ISO 13485 is a process based standard. When followed, these processes ensure a quality end product.

Organizations or businesses receive ISO certification. Individual people cannot become certified in ISO 13485. However, one person in an organization can receive certification as an ISO 13485 Certified Lead Auditor.

Becoming ISO 13485 Certified

Organizations wishing to become ISO 13485 certified must meet strict requirements. This is necessary to ensure the organization fully understands the processes required to create high quality medical devices. Organizations must take all necessary steps to implement an ISO 13485 quality management system. They must then undergo an audit by a Certification Body (CB). If the organization passes the audit, they receive ISO 13485 certification for three years. They must get re-certified after the initial three-year period.

ISO Certified Medical Device Manufacturer

Means Engineering has the people, equipment, and technology needed to produce high quality medical devices. In addition to ensuring the proper practices and standards within our organization, we have taken the steps necessary to become ISO 13485 certified. This puts us in the best possible position to help with the design and production of a wide range of products.

When you work with Means Engineering, you gain access to the knowledge and experience of our highly qualified team. We work directly with our clients to ensure adequate communication throughout the entire process. Please contact us to learn more about our contract manufacturing services for the medical industry.

Creating High Quality Medical Devices

August 14, 2020 By meiadmin

Medical devices help ensure quality of life for people around the globe. Used for a variety of diagnostic and treatment purposes, these devices play an important role in safeguarding the well-being of our increasingly health conscious population. Thanks to medical devices, diseases get caught earlier, improving outcomes and decreasing the cost of healthcare for millions of Americans.

Medical Devices Must Meet Strict Regulatory Requirements

When it comes to medical device creation, it’s crucial that organizations follow strict guidelines to ensure the production of high quality and reliable products. Regardless of intended use, medical devices face some of the toughest regulatory guidelines of any industry. It is up to developers and innovators to understand these regulations and ensure compliance when designing and producing devices for the medical industry.

In the United States, medical devices are regulated by the Food and Drug Administration (FDA) and the Centers for Devices and Radiological Health (CDRH). Based on associated risk, medical devices receive a Class I, Class II, or Class III classification. While Class I devices carry the lowest associated risk, Class III devices have the highest. The level of regulatory control depends on device classification.

Outsourcing Medical Device Design & Production

Companies looking to enter the medical device industry often find it difficult and confusing to understand the different CFR’s associated with the design, development, labeling, and production of medical devices. This is enough to keep many organizations out of the medical device industry altogether. However, this probably isn’t the best choice. The medical device and diagnostic industry is worth over $300 billion.

Organizations looking to produce high quality medical devices could benefit significantly from partnering with a trusted medical contract manufacturing service provider. Outsourcing to an ISO 13485 certified contract manufacturer ensures the production of high quality devices that meet strict regulatory compliance requirements. But this is just one piece of the puzzle. Organizations must also look for a partner that’s easy to work with and understands the importance of treating their staff and partners with the respect and attention they deserve.

Southern California Medical Device Contract Manufacturer

Means Engineering works directly with each of our valued customers to help develop a solution that exceeds their expectations in regards to both quality and care. Our vertically integrated approach makes it possible for partners to maintain control and monitor every step of the manufacturing process. By handling everything in-house, Means Engineering provides increased visibility and simplified supply chain coordination.

If you’re considering venturing into the medical device industry, or you require assistance with your existing medical device design and/or production, we encourage you to contact us to see why we’re the Southern California contract manufacturer of choice. We look forward to hearing from you.