FEATURED EDITORIAL

Human Factors Align At The RAPS 2017 Regulatory Convergence
Human Factors Align At The RAPS 2017 Regulatory Convergence

Recently I had the privilege of co-presenting a session at the RAPS 2017 Regulatory Convergence with former colleagues from Regulatory & Quality Solutions (R&Q) and members of the FDA. Read more about the session here. 

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INDUSTRY INSIGHTS

  • Improving Health Outcomes With Personalized Apps
    Improving Health Outcomes With Personalized Apps

    Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.

Micro-MIM Succeeds At Making Precise Micro Metal Parts

As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.

Plan For Success With Sustaining Engineering In Medical Device Development And Manufacturing

A key aspect to a successful medical device development project is a dedicated outsourcing partner who can provide engineering expertise that includes sustaining engineering. Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. This article discusses the importance of sustaining engineering, and KMC's executive director of engineering, Scott Leon, weighs in on the subject.

How To Uncover The Hidden Value Of Culture In Supplier Selection

The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.

Taking Micromolding To the Next Level

Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production. 

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SOLUTIONS

In Vitro Diagnostics

Battelle brings together deep experience in bioinformatics, biologics, chemistry and related fields to deliver innovative in vitro technologies with unparalleled accuracy and detection limits — all at unprecedented speed and with significant cost savings.

Medical Device Prototyping & Design Services Medical Device Prototyping & Design Services

Carclo's product engineers have multiple years of experience with medical device prototyping and design. They address your medical device design needs by getting involved as early in the product prototype and design cycle as possible.

Laser Beam Profilers Laser Beam Profilers

Laser beam profilers are the optimal solutions for increasing chances of success in the design or applications of new lasers, or when a laser system is no longer meeting the desired specifications. Ophir Photonics offers a wide range of beam profiler choices including CCD and CMOS cameras, scanning slit sensors, InGaAs and pyroelectric cameras, and pinhole and knife edge sensors.

Detergent 8: Low-Foaming Ion-Free Detergent Detergent 8: Low-Foaming Ion-Free Detergent

Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues.

Lab Testing And Sterilization Validation Services Lab Testing And Sterilization Validation Services

REVOX has put together a team comprising engineers, chemists, microbiologists, project managers, business consultants, and quality and regulatory professionals that are subject matter experts with strong expertise and experience in their fields. REVOX can work to enable sterilization technology to work to its fullest potential for medical devices. The company offers rapid 30-day sterilization development, materials and microbiological laboratory testing, supply chain optimization services, and regulatory development expertise.

Standard Solutions and Containers Standard Solutions and Containers

B. Braun provides an array of parenteral pharmaceutical solutions, including those for use in standard IV, irrigation, nutrition, and anti-infective therapy applications. The EXCEL® and PAB® containers and the DUPLEX Drug Delivery Systems feature biologically inert, PVC-Free and DEHP-Free, non-toxic plastic construction for a safe and accurate method of administering IV medication.

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FEATURED SUPPLIERS

Caplugs Caplugs

Caplugs, a global leader in protective solutions since 1948, offers extensive custom molding capabilities and a catalog of products available for same day shipment for the medical industry. With more than 1,300 medical customers, a series of ISO certifications, a Class 8 certified Clean Room and a stringent quality control process, Caplugs understands the unique challenges and needs of the medical field. Whether you need a custom molded solution or an in-stock component, our dedicated team of medical experts is available to guide you through the process.

Alconox, Inc. Alconox, Inc.

With more than 60 years of experience in formulation of quality aqueous cleaners, Alconox Inc. understands the cleaning needs of the medical device manufacturing industry including stringent FDA regulations and GMP compliance.

MDO-FTE-bmarshall

 EVENTS

Medicall October 6 - 8, 2017
Mumbai
Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success October 10, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Aging Aseptic and Biological Manufacturing Facilities - Renovation for Survival October 11, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
How to Write SOPs That are GCP Compliant and Implementable October 17, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Best Practices in CMC Dossier Preparation – Facing Tough Challenges October 19, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Combination Products October 24 - 26, 2017
Amsterdam
Clinical Study Requirements – Understanding Differences Between the US and EU November 14, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Medical Plastics & Compounding Conference December 5, 2017
San Jose, CA
Companion Diagnostics Forum (CDx) 2017 December 6 - 7, 2017
Princeton, NJ
1st Emirates Family Medicine Society Conference January 11 - 13, 2018
Dubai, UAE
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