Plainfield Precision Achieves ISO 13485:2003 Quality Management Certification for Medical Device Manufacturing

Plainfield Precision, a global leader in medical device manufacturing, announced today that it has earned the International Organization for Standardization's (ISO) 13485:2003 certification for their "plastic injection molding, metal stamping, assembly and manufacturing of medical devices".

Aug 1st, 2012

Plainfield Precision's certified quality management system produces the highest quality products and components for its clients based on the stringent requirements set by ISO 13485:2003. The certification cover's Plainfield Precision's facilities in Plymouth Massachusetts, Sturgeon Bay Wisconsin and the Dominican Republic.

"This certification is an independent confirmation of our dedication to achievement of the highest-quality production and services that meet the needs of our customers," said Jonathan Soucy, President of Plainfield Precision.

Companies receiving the ISO 13485:2003 certification must demonstrate their ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Plainfield Precision's review was completed by NQA, one of the largest and most respected ISO registrants in the world.

"Achieving our ISO13485 certification has validated our processes and controls and has demonstrated our commitment to providing high quality products and services to the medical device industry," states Soucy. "Having this in place will provide our customers with a high degree of confidence in our already well-established medical device manufacturing expertise."

Plainfield Precision

No automation needed to be replaced with the switch from PET to aluminum, which was good news for Nature’s Baby. The existing filling line is capable of handling the new aluminum bottles with limited adjustments.

Organic Baby Shampoo & Conditioner Brand is Latest of its Ilk to Go All-In for Aluminum

Nature’s Baby Organics is another recent entry in the shift away from plastic, and toward aluminum, for packaging of personal care and bath products, particularly specialty products with elements like vegan, organic, or cruelty-free.

Adoption of AI in validation and other processes, including data collection and management, can result in valuable predictive qualities within a manufacturing facility.

Data and AI Accelerate Digital Transformation in Pharma

The PDA Annual Meeting emphasized the growing need for pharma manufacturing facilities to become digitalized to improve productivity, open the door to further technologies, and make the most of the ‘digitally native’ workforce.

Sm Graphic Cannanis Soonke

CANnabis or CAN’Tabis: Where is Cannabis Heading Amid New Administration?

Healthcare Packaging's director of editorial content talks new directions for cannabis regulation, packaging updates, consumer behavior, and more.

Could FDA's ASCA program save submission time and boost pre-market testing consistency in the medical device industry?

Demystifying FDA’s ASCA on Biocompatibility for Expedited Review

The SentiAR Wearable Command Center is an interprocedural augmented reality (AR) system—with the user interface built off the Microsoft HoloLens—that enables the electrophysiologist to model the heart.

Medical Product Changes Stemming from User Centered Design

Live from MD&M BIOMEDigital: a startup, a consultancy, and a large brand owner talk about how interacting with end users changed their medical device and machinery designs.

The difference between IT and OT cybersecurity attacks.

Cybersecurity 101: The Difference Between IT and OT Attacks

There are two categories of cyberattacks, but they can create a bridge to one another, creating a potential avenue for cybercriminals to access the organization.

Hcp Title 60661e958299d

5 Tips To Improve Your Remote/Hybrid Audits

Whether you’re a manufacturer or contract organization, audits are a key part of ensuring quality. Don’t overlook these tips from our 'Take Five with HCP' video when switching from in-person supplier audits to virtual or hybrid audits in the pandemic.

Communicating acceptance criteria with your lab is key in mechanical testing of passive shippers.

Mechanical Testing for Passive Thermal Coolers: Practical Q&A for Life Sciences

Live from ISTA’s TempPack: Experts discuss acceptance criteria guidance, payload selection, actual product versus placebo, testing multiple product configurations, and more.

Critical components need to be assessed to achieve a robust cybersecurity system.

Manufacturing Cybersecurity: Critical Components for Risk Assessment

By the second quarter of 2020, cyberattacks targeting manufacturers accounted for 33% of all incidents across all industries with losses totaling hundreds of millions of dollars. Small businesses are also at risk.

A prototype based on a single-click pump in collaboration with supplier NeoCeram.

Reducing Aseptic Risk During Filling

At #PDAannual, Novo Nordisk discusses innovative solutions to modernize aseptic filling in existing facilities while minimizing downtime, regulatory impact, and rebuild.

Each 'bird type' has specific ways of communicating, receiving information, and responding to crises.

Use ‘Bird Styles’ to Improve Your Communication in Crisis

Tips for communicating in a crisis so that people listen. Says one consultant, 'If you find yourself carefully crafting an email because you're instinctively cautious about how it might be received, don't write it.'

2021 Ista Virtual Forum Noblue

ISTA Forum Focuses on Packaging for Transport, and Temp Controlled Packaging

The 2021 Virtual ISTA Forum, including TransPack and TempPack, will be held on Tuesday, March 30th and Wednesday, March 31st.

GOLD AWARD—Technical Innovation—Amcor's Dual Chamber Pouch by Amcor Flexibles

Dual Chamber Pouch Keeps Medical Devices Safe

The FPA honored Amcor with a Gold Award in Technical Innovation for its Dual Chamber Pouch, a specialty multi-layer pouch consisting of a peelable medical device chamber and a non-peelable desiccant chamber.

Getty Images 858168758 Copy

Blow-Fill-Seal Expands in Aseptic Filling, Vaccines

Live from #PDAannual: Recent developments in the technology have bolstered the use of BFS in aseptic processing, including temperature control and needle addition for pre-filled syringes.

Getty Images 1060972482

5 Tips on Remote Auditing Contract Organizations

Switching to hybrid or virtual audits? Check out these tips for a smoother transition. Additionally, PDA is holding a remote audit and inspection workshop Apr. 8.

'Your lovin' gives me a thrill, but your lovin' don't pay my bills.' From Money (That's What I Want) first released in August of 1959, written by Motown's Barry Gordy and Janie Bradford.

How does Your Salary Compare?

Are you among top earners or are you sorely in need of a raise? Calling for industry-wide response to annual salary survey conducted by IoPP and covered in Packaging World Magazine.

An exploded view of the Fatty 15 starter kit demonstrates the use of corrugated inserts to safely handle a glass bottle through the many-touchpoint e-comm channel in a compact format without extra space or the need for dunnage.

Subscription D2C Supplement Brand Makes Sustainable Impression at Unboxing

A new-to-science fatty acid supplement promises to improve longevity. Seraphina Therapeutics created a sustainability-minded D2C packaging and unboxing experience to align with and amplify the discovery.

HIGHEST ACHIEVEMENT AWARD—Crunch Pak's Toy Story Lunch Kitz by American Packaging Corp.

FPA Announces 2021 Flexible Packaging Achievement Award Winners

The Flexible Packaging Association (FPA) announced the winners of its 65th Annual Flexible Packaging Achievement Awards Competition.

Customers across the U.S. can now shop online at Loop by Ulta Beauty for beauty and personal care products in durable, sustainable packaging that can be returned for refill.

Ulta Unveils First-of-its-Kind Circular Beauty Packaging Platform

Beauty retailer Ulta partners with circular shopping platform Loop to develop an online site and system for consumers to order products in durable, reusable packaging that can be returned for refill and reuse.

Part 2: RFID Labels Open Doors for Continuous Supply Chain Improvement

In this Q&A, a manager of pharmacy operations explains why RFID-embedded vial labels just may change the world of inventory management and dispensing.

More in Home

With the CCL/Kit Check partnership, manufacturers receive labels with RFID inlay that appear identical to their existing label—and don’t require artwork changes and new FDA approval—and do not affect packaging lines.

Part 1: From Drug Supply to Staffing, the Benefits of RFID Integrated into Vial Labels

In this Q&A, a manager of pharmacy operations explains why RFID-embedded vial labels just may change the world of inventory management and dispensing.

I Stock 000021206803 Large

Modular: The Modern Way of Manufacturing Injectables

Flexibility allows manufactures to meet the needs of the growing and versatile injectables market.

In 2020, the natural and organic products industry grew to $259 billion.

Update on the Natural and Organic Market Today

In 2020, the natural and organic products industry grew to $259 billion, an increase of 12.7%, with sales on track to pass $300 billion by 2023.

A technician working on the Mars 2020 Perseverance rover mission takes a sample from the surface of sample tube 241 to test for contamination. Each sample tube has its own unique serial number (seen on the gold-colored portion of the tube). The image was taken in a clean room facility at NASA's Jet Propulsion Laboratory in Southern California, where the tubes were developed and assembled.

NASA’s Tubes Withstand the Trip to Mars

With the successful touchdown of the Perseverance Rover on Mars in February, we look at the tubes powering data collection.

Medical Vials Cold Chain

Part 2: COVID-19 Squeezes the Cold Supply Chain

Keren Sookne, content director at Healthcare Packaging, discusses supplier efforts to move COVID vaccine forward, its effect on the cold supply chain and its toll on workers and infrastructure.

MWC, Kraft Heinz, and CTI Foods Named Winners of Manufacturing Innovation Awards

The award-winning food companies will reveal technology highlights of their projects and be honored during a special session at PACK EXPO Las Vegas, September 27-29.

Getty Images 1292560713

Part 1: Logistics in the Vaccine Rollout

Keren Sookne, content director at Healthcare Packaging, discusses vaccine logistics, ice-cream freezers, and more.

3 Key Takeaways from the EMA Clinical Trial Guidance Update

New version addresses remote source data verification amid the COVID-19 pandemic.

To protect the QuickVue kit against moisture and other environmental conditions, the company integrated Aptar CSP Technologies’ Activ-Film technology.

Film Technology Protects COVID-19 Diagnostic Test Strips

The new QuickVue SARS Antigen test from Quidel incorporates active packaging technology to protect from moisture and other environmental conditions that could otherwise impact accuracy.

IoT-Enabled Reusable Packaging: Making Smart Supply Chains Smarter

The newest Inner Loop article from the Reusable Packaging Association emphasizes the growing role of IoT-enhanced reusable transport packaging in creating efficient, agile supply chains to deliver smarter products to customers reliably.

The resource kit contains booklets, pamphlets with stands, flip charts, pocket information guides and two sample cartons containing placebos.

Updatable Pharma Kit Packaging Saves Co. $200,000 and Counting

Incorporating a kit with a slide cover is providing production flexibility and cost savings—updating the kits only means replacing one component.

XPlanar eliminates the need to move the plasma jet; instead, a floating planar mover carries the workpiece into position for precise surface treatment. Source: Plasmatreat

OEM Redesigns Equipment to Incorporate XPlanar Floating Movers

The levitating material handling technology from Beckhoff is being used by Plasmatreat in its equipment to position materials beneath spray nozzles for plasma pre-treatment and coating.