Category: Medical Device Manufacturing

What are the Validation Activities Involved in Medical Device Manufacturing?
Medical devices are unique in that a malfunctioning device can be the difference between life and death. For that reason, the Food and Drug Administration has strict regulatory requirements that medical devices must meet. Known as “medical device validation”, the process for ensuring the proper design and function of these lifesaving devices applies to the development, production, and sales of the devices. In other words, validation activities include all demonstrations that medical devices must meet the FDA’s performance and safety standards.

Steps Involved in Medical Device Validation

The FDA allows for a bit of flexibility in how manufacturers achieve validation, once the design of the device has been verified. However, irrespective of the type of medical device, the following activities will be required:
- Each manufacturer will establish their own procedures for validating the device
- Each device must be manufactured under defined operating conditions
- All devices must conform to defined user needs and intended uses. Testing of production of the units shall be performed under simulated use or actual use conditions.
- Manufacturers must maintain a Design History File which includes methods used to validate, and the individual overseeing the validation.
- There are also protocols for methodology to demonstrate that the equipment being used in the manufacturing process will offer a high degree of quality assurance such that production processes will consistently manufacture products that meet quality requirements. Such protocols often used are IQ, OQ, PQ:
  - Installation Qualification (IQ) verifies that an instrument or unit of equipment being qualified (as well as its sub-systems and any ancillary systems) has been installed and configured according to the manufacturer’s specifications or installation checklist.
  - Operational Qualification (OQ) involves identifying and inspecting equipment features that can impact final product quality.
  - Performance Qualification (PQ) is the final step of qualifying equipment. In this phase, the qualification and validation team verifies and documents that the user requirements are verified as being met.
Who is Responsible for Medical Device Validation?

It is up to the manufacturer (OEM) to assume responsibility for the safety and proper function of medical devices. To that end, most companies appoint a high-level Quality Control employee to manage the validation process.

Whoever is selected to construct and oversee the validation activities needs to have a thorough understanding of all applicable regulations. Keep in mind that regulations require that the design of the device not only meets user needs but accomplishes the desired function. To put it another way, the individual tasked with overseeing validation activities will be in charge of confirming that their company built the right device for its intended use.

Benefits of Manufacturing Medical Devices in Mexico

Nearshore manufacturing of medical devices, when performed by an established, and reputable contract manufacturing partner can save time and money. However, due to the strict regulations and quality standards governing medical devices, it’s essential that you select a contract manufacturing partner with proper engineering resources that specializes in medical device manufacturing.

Working with an FDA Registered contract manufacturing partner in Mexico offers benefits including:
- Trained, affordable workforce
- Close proximity to the U.S.
- Lower shipping costs
- Greater oversight
- Tax benefits
- Faster production-to-market times
- Less vulnerable to supply chain disruptions
- Less risk of Intellectual Property theft
- Free trade agreement with Mexico
Indeed, medical device manufacturing in Tijuana allows you to reap the benefits of savings, without sacrificing oversight and quality control due to distance.

Learn More About Medical Device Manufacturing in Tijuana

In 2022, Coastline International celebrated 40 years of success in nearshore medical device manufacturing in Mexico. Coastline International boasts an operational capacity of more than 50,000 square feet and 4 separate ISO Class 8 cleanrooms in facilities built to U.S. standards. As a privately owned, San Diego, CA-based U.S. corporation, Coastline International specializes in medical device, electronics, aerospace, and consumer goods manufacturing. To learn more, send us a message or call 888-748-7177.
January 10, 2023
Coastline International Celebrates 40th Anniversary

We are excited to celebrate our 40th anniversary this year for manufacturing in Mexico! Here is the press release posted to share the story. We are looking forward to many more years ahead!

SAN DIEGO (April 2022) — 2022 marks the 40th anniversary that Coastline International has been providing manufacturing services for leading companies worldwide. Established in 1982, Coastline has a long history of working with top OEMs to provide superb customer service and manufacturing partnership through their Tijuana, Mexico based facilities. Coastline has gained a reputation for their quality and service throughout the past 40 years of becoming experts in nearshore manufacturing.

Why Contract Manufacturing in Mexico?

While Coastline’s manufacturing operations are strategically located on the Tijuana side of the US-Mexico border, Coastline International is a US-owned and managed company and all corporate operations are based out of San Diego, California. Since its inception in 1982, Coastline has operated the same maquiladora business model which encompasses the management of all manufacturing services and import-export activities for their customers to allow for seamless access to their highly skilled and competitive labor workforce in Mexico.

In the early 1980’s and 1990’s era, Coastline was primarily concentrated on electronics and industrial applications. Core competencies focused on printed circuit boards (PCBA), soldering, potting, wire harnesses, box builds, manual packaging, assembly of aerospace rivets & fasteners, and power supply & battery pack assembly. Coastline capabilities have historically aligned with industry demands, and in the late 1990’s, the requirements of the medical device industry found their way to Coastline Mexico facilities. As the manufacturing and assembly processes for many medical products were and continue to be quite labor intensive, it was made very clear that the manufacturing infrastructure in the Tijuana region was a great fit to support the emerging market. With Coastline’s history of high-quality assembly work, it was a natural transition to embrace new medical companies as customers.

Coastline International’s Evolution Over the Years

Over the years as the opportunities grew, Coastline continued to evolve and adapt to the industry requirements. In the early 2000’s, Coastline obtained ISO certification and to this day the Quality Management System remains current on both ISO 9001 and ISO 13485 revisions. The Coastline facilities in Mexico have built a robust staff and experienced management team which has continued to grow along with the development of their customer base. In 2018, Coastline obtained a new 20,000 sq. ft. building and invested in the build-out of an additional Class 8 (Class 100,000) cleanroom production space. The Tijuana facilities currently comprise a total of three buildings which include four cleanrooms and multiple production floors & warehouses across the 50,000 sq. ft. campus – all of which is in the same secure gated industrial park approximately 10 miles from the San Diego border.

Throughout the past 40 years, the focus on manual assembly has been a common denominator across the vast portfolio of products manufactured at Coastline. As Coastline has adopted new customers in thriving industries, legacy production also certainly remains from many long-standing customers, some of which have been engaged for more than 20 years. Although labor-driven processes continue to remain a core proficiency, Coastline has also embraced significant equipment-reliant manufacturing capabilities such as ultrasonic welding, RF welding, UV curing, die-cutting, sterile-barrier sealing, in addition to automated processes such as form-fill-seal (FFS) packaging.

Coastline’s customer base covers a wide spectrum of companies across industries which include Fortune-500 companies, late-stage start-ups, and many organizations in between. All of Coastline’s customers either have a long history of successful products or have created traction in the marketplace with new innovation. In order to support their growth, it has been essential for these OEMs to identify a strategic manufacturing partner to help reduce costs and also provide the capacity to scale production for the growing demand. By working with Coastline, these companies have been able to rely on the Tijuana site for scalable production – consequently, they can focus on product development, innovation, sales & marketing, and all of the other critical aspects related to the demands of a successful modern company.

The management team at Coastline has committed to creating a culture of integrity within the organization. As a result, Coastline has been fortunate to maintain turnover levels considerably below the regional and industry averages. Coastline has also found great success through focusing on employee development and internal promotion in order to create opportunities for current personnel. Many of Coastline’s employees have been with the organization in excess of 10-20 years, some even passed the 30-year mark. Over the years, hundreds of jobs have been created by way of Coastline’s manufacturing operation in Tijuana and the future is looking bright with continued growth ahead.

In conjunction with a passion for their employees, the other element fundamental to their success has been the dedication to service for their customers. Coastline has been recognized for their service offering which includes management presence from the USA on-site; this “boots on the ground” approach of US-management representation embraces the partner mentality and creates a direct line of communication to the manufacturing site. Coastline has countless times been able to witness firsthand the lifecycle of products ramping from early design-phase all the way to steady-state high volume production lines. The accomplishment of their customers is vital to Coastline’s success, as the mutually beneficial relationship is based on reciprocity and the spirit of partnership. Coastline’s goal is to truly operate as a “Tijuana-based extension” of their customers.

A Bright Path Forward

As 2022 will make 40 years of manufacturing in Mexico for Coastline International, the organization is committed to many more positive years ahead. The leadership team is very excited about Mexico’s position — Tijuana in particular — in the current global landscape for contract manufacturing. In addition to facility investments, Coastline has continued to invest in its staff to build and maintain the necessary foundation for further steady growth and an exciting future to come.

To learn more about Coastline or contact for manufacturing inquiries, please contact Brett South at: info@coastlineintl.com

April 15, 2022
Your Guide to Medical Device Manufacturing in Mexico

If you’re an American business searching for a medical device manufacturer, you don’t have to look across the ocean to another continent — the right solution may be closer than you think. Medical device manufacturing in Mexico is a booming industry thanks to its skilled workforce, high tech facilities, and close proximity to the United States. At Coastline International, we’ve been manufacturing medical devices for our partners since 1982. Here’s what you need to know about the process.

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May 25, 2021