EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Manufacturers
Eric Clement Arakel and Myriam Gueye explain the effect the newest form of the guidance has on both medical device and pharmaceutical manufacturers.

10 Things You Should Do Before You Validate Your Next Package
Before you set out to validate a medical device package design or process, you’ve got to do your homework. DDL offers the following 10 points to consider before beginning any validation effort.

ASTM versus ISTA for Distribution Simulation Testing
Many medical device manufactures struggle on a daily basis with what they need to do in order to comply with ISO 11607 and which procedure to utilize for performance testing, ASTM or ISTA. The following paper compares how each procedure outlines distribution simulation testing.

ISO 80369-7: Changing the Standard for Luer Connectors
This paper highlights the changes that most significantly affect how one should construct their design verification plan

How to Clear a Medical Device with the FDA
This whitepaper discusses the standards and requirements needed for a successful FDA submission and clearance for a software medical device, and also defines pre-market v.s. post-market activities, submission timelines, CFR, XGMP, QMS, and DHF. It provides resources for businesses that help to ensure regul...

3P510(k) - An Alternative to Traditional FDA Review
BeanStock Ventures is one of only nine FDA-accredited Third Party Review Organizations globally. This means that we can review select product codes on behalf of the FDA in a fraction of the time! A traditional FDA 510(k) review takes, on average, 31 months. We can review your product in as little as 47 day...

Guide to Verification and Validation
Prevent Unexpected Design Failure Verify and Validate Your Product's Design and Usability.

Medical Device Development Guide
Avoid Medical Device Project Roadblocks.

How to Prevent Motor Overheating in Surgical and Medical Power Tools
Motors in handheld surgical tools and other medical devices can get very hot when operated at their rated torque limit. In continuous operation, motor windings can reach 155°C resulting in a housing temperature of some 120°C. No surgeon would like to operate with a hand-held tool not even at half of that t...

How the Industrial IoT Can Improve Your Manufacturing Excellence
This white paper, titled, “Transformation Acceleration – How Manufacturers Can Overcome Challenges with the Right Tools & Tech,” details, using research from IDC, manufacturing supply chain slowdowns, worker shortages, product shortages, and agility issues and solutions. These include Industrial Internet o...

Supply Chain Resilience in Medical Manufacturing
The resiliency of scope and scale when overseeing the supply chain in medical manufacturing

Relationship Advice for Manufacturers
How to Tell When Your Contract Manufacturer is “The One”

Sustainable Teamwork
Design and Manufacturing Partnerships for a Circular Economy

MEMS and Manufacturing
How Tiny Microelectromechanical Systems are Sparking Innovations in a Big Way

The Circular Economy
What it is and Why Manufacturers Should Care

Improving Injection Molding Processability Using Transparent Medical ABS Resin
This White Paper presents processing and injection molding details for TOYOLAC® ABS transparent medical resin providing significant cost-advantages when injection molding TOYOLAC® due to lower operating temperatures and lower pressure requirements compared to polycarbonate.

Toray TOYOLAC MEDICAL TRANSPARENT ABS 909 MG1 White Paper
The Effects Of Electron Beam And Gamma Sterilization On Transparent Resin Used In Medical Devices

Toray RAYTELA™ Plastic Optical Fiber White Paper
RAYTELA™ Plastic Optical Fiber Is Ideal For Minimally Invasive Surgery

Dark Marking with Picosecond Lasers
Ultrashort pulse lasers create high contrast dark or black marks that are resistant to passivation, corrosion, and autoclaving and that meet federally regulated UDI standards for medical devices. 

Laser Stripping for Medical and Electronics Industry
Automated laser processes increase production efficiency, process control, and product innovation

Field Oriented Control (FOC) - A Deep Dive
DC Brush, Brushless DC (BLDC) and step motors are the three most commonly used motor types for positioning and velocity motion control applications. Of these, Brushless DC and step motors are 'multi-phase', meaning they require some type of external coil excitation to keep the motor moving. This...

Formulated for an Era of New Challenges
Elastomer Material Flexibility Optimizes Performance and Meets New Challenges

Motion Control Technology Trends for Medical and Laboratory Applications
In this article we will look at four important trends in motion control technology for applications involving medical and laboratory equipment. These applications include automated devices used during surgery, for patient treatment, for patient imaging, and the wide variety of machines that operate in the ...

Creating Toxicological Risk Assessments for Medical Devices
There has been a substantial regulatory emphasis on obtaining chemical information about a medical device. But how does one take that information and translate it to patient safety? This is where ISO 10993-17 and toxicological analysis come into play. In this document we will outline the process b...

A Guide to Finding Your Perfect Fit - CONTRACT MANUFACTURER
When it comes to choosing a contract manufacturer (CM) is bigger better or do you prefer the person touch small CMs provide? Whatever your preference, there are certain advantages and disadvantages to CMs of different sizes. The trick is striking the best balance between these two options.

DISPELLING MYTHS ABOUT DOING BUSINESS IN CHINA: How “The World’s Factory” Protects Your Intellectual Property
Historically, foreign companies operating – or planning to operate – in China have been apprehensive about the safety of their intellectual property. This is reflected in yearly surveys conducted by the American Chamber of Commerce in China (AmCham China) as well as the US-China Business Council, in whi...

How to tell whether Providence is… or isn’t… THE PERFECT FIT CM FOR YOU
Why is it so difficult to find the right contract manufacturer? After all, you are spoiled for choice, with hundreds of thousands of companies of varying sizes and specialties. It’s precisely because of the cluttered market that choosing the best among them is so difficult. Plus, there’s a high risk to ...

INTELLECTUAL PROPERTY: How to Protect Your Big Ideas in a Global Supply Chain
Protecting intellectual property has always posed challenges, in large part because IP deals with something intangible: the thinking behind innovations. You can’t build a fence around ideas, post armed guards to protect them, or even firewall them.

How CM Expertise Helps You Control Costs
A good contract manufacturer fills the gaps in their partners’ skills, capacity or capabilities. In other words, they deliver what you pay for. A great contract manufacturer does so much more.

STRATEGIES FOR CONTINUITY: Dealing with Disruptions and Global Material Shortages
The global supply chain has taken a battering over the past 20 months, curtailing the availability of critical components and materials, from semi-conductors to plastics.