With the American Medical Device Summit quickly approaching, we took the time to sit down with one of our industry partners, Stratos Product Development, to gather their thoughts on the biggest medical device development challenges and the best practices to overcome them. Check out the Stratos eBook to explore : Complications arising from a lack of proper documentation, and how to overcome them. Strategies to speed the product development process while effectively managing costs. Tactics to make product launches more predictable. Regulatory considerations that need to be factored into the medical device development process in the U.S. The benefits of outsourcing innovation. eBook, Medical Device Development Best Practices For more insights into medical device development, commercialization and manufacturing, join Stratos at the American Medical Device Summit 2016 taking place in Chicago on October 5th – 6th, 2016.
Read More →eBook: Q&A with Brandon Varnau, Vice President and Head of Operations Quality, Sanofi Specialty Care
Our next eBook features industry insights and forecasts from Brandon Varnau, Vice President and Head of Operations Quality at Sanofi Speciality Care, one of the key speakers at the American Biomanufacturing Summit 2016. We asked Brandon: How biomanufacturing in the U.S. differs from international operations? What are the biggest challenges biomanufacturers currently face? How can these challenges be overcome? What is the biggest opportunity in biomanufacturing? What do you foresee as the ‘next big trend’ to influence biomanufacturing? What major changes to you forecast the industry undergoing over the next 5-10 years? eBook Q&A with Brandon Varnau Brandon joins the speaker line up in San Diego this May to discuss strategies to Create a Quality Compliance Culture Within Biomanufacturing Facilities: Aligning manufacturing and quality objectives to ensure compliance Developing clear compliance expectations for all staff Empowering staff to proactively engage in a culture of compliance Examining various channels and knowledge sharing platforms to communicate compliance practices Find out more about the sessions, case studies and key themes to be addressed at the American Biomanufacturing Summit 2016!
Read More →Infographic: The Guiding Principles of a Quality Management System
In today’s infographic we take a closer look at the guiding principles of a quality management system (QMS). The goal of a QMS is to maintain compliance, drive continual improvement and support efficient and flexible processes. A QMS is first established by assessing the short-falls of the current system and developing appropriate policies to achieve corporate quality goals. Once these are defined the standard operating procedures need to be implemented and personal buy-in from all levels of the organization must be achieved. Management will then monitor and review the outcomes, making additional adjustments to ensure continual improvement. Check out the infographic below for some quick insights on creating and monitoring a quality management system. For more in-depth information, strategies and best-practices attend the American Biomanufacturing Summit 2016 in San Diego this May.
Read More →Best Practices for Medical Device Development
Medical device developers must take into account numerous safety, quality and risk factors to ensure the durability and safety of their devices. Developers must also adhere to strict risk management processes and life cycle requirements that may vary regionally. Our friends at Seapine Software have generated the whitepaper below to help developers navigate this shifting terrain and understand the best practices for exposing risk throughout the product development life cycle. Exposing Risk Throughout Your Product Development Lifecycle Hear more from Seapine Software by joining the discussion at the American Medical Device Summit 2016!
Read More →Infographic: Building a Culture of Quality in Biomanufacturing
Quality management is a key focus at the American Biomanufacturing Summit 2016. Manufacturers are facing increased pressure to reduce product costs while producing “bio-better” drugs that have a vastly improved pharmacological profile. By implementing a quality management system biomanufacturers will be able to build consistency into their processes, improve efficiency, ensure profitability and drive operational and competitive advantages. Implementing a quality management system is no easy feat, the process requires an organizational evolution and involves the optimization of procedures, processes and resource allocation. To enable these changes an organization must first work to build an organizational culture that focuses on quality. The first infographic in our quality series has been created from the information presented by Tony Mire-Sluis, Vice President, North America, Abingdon, Singapore, Contract and Product Quality, Amgen Inc., at the American Biomanufacturing Summit last year. Find out more about building a Culture focused on Quality at the American Biomanufacturing Summit 2016!
Read More →Finding the Balance: Compliance, Product Development & Quality Management
Manufacturers are always looking for ways to speed their time to market and reduce production costs without compromising quality. Those who operate in highly regulated industries also have to ensure that their processes remain compliant with regional regulations. It can be challenging for manufacturers within these industries to find ways to improve both the product and the development process without compromising compliance. To help manufacturers navigate this terrain Seapine Software has released the whitepaper below. The whitepaper addresses strategies to achieve efficiency goals by balancing three functional areas: regulatory, development and quality management.
Read More →Infographic: 5 Questions that Lead to Better Supplier Management & Performance
Take a closer look at the infographic: SQA Services- Supplier Performance Management (1) Find out more about SQA Services online, or Join SQA at the upcoming American Manufacturing Summit 2016, taking place on February 29th – March 1st in Chicago!
Read More →Not All Parts Are Created Equal: Choosing the right CNC Machining Company for the Aerospace Industry
Precision machining techniques are needed to produce aerospace components that are instrumental throughout an aircraft. These components are often ‘life-critical’, intricate parts that need to meet very precise specifications with high tolerance thresholds. “Quality is a given, because these parts are going in jet engines and landing gear, all across an airplane. It’s what we call ‘life-critical’. There is no room for failure.” explains Scot Barton, VP Sales at Pointe Precision. Given the vital nature of the components, selecting the right CNC Machining partner is a critical aspect of an aerospace manufacturers’ process. When selecting a CNC Machining partner there are a couple of key factors to consider: Technological Capabilities When it comes to machining high quality precision parts, the first and most important aspect is the in-house equipment that your potential partner is utilizing. The ideal machining partner will have: A full complement of high-quality machines with the ability to process large volumes quickly and seamlessly. Multi-tasking capabilities to allow machining in a single operation as opposed to only offering multi-fixture operations. This machining capability will allow for greater reliability in the generation of aerospace parts. Multi-tasking capabilities also allow for improved internal flexibility as operators move from machine to machine, going where the work is. Sam Crueger, Engineering Manager at Pointe Precision explains that “the quality is (also) better when a part can be completed on a single machine.” ‘One-Stop-Shop’ offerings: Ensuring that all of your CNC Machining …
Read More →Whitepaper: Avoid 4 Common Pitfalls of Designing an OpenVPX™ System
OpenVPX is a COTS technology, used in rugged C4ISR designs, which reduces risk, so why are delays and overruns so common during the design phase? There are a number of common pitfalls that, unless avoided, can wreak havoc on OpenVPX designs. Atrenne Integrated Solutions, an organization that has over 40 years of experience in COTS designs for military and aerospace rugged computing, has identified the 4 most common pitfalls in designing an OpenVPX System. These errors and misconceptions can throw off your schedule, overrun your project budget and knock your well-conceived VPX project off the rails.
Read More →The Benefits of Concentricity
“In GD&T, concentricity is a complex tolerance used to establish a tolerance zone for the median points of a cylindrical or spherical part feature. Concentricity is generally reserved for high-precision parts when there is a need to control median points.” – eMachineShop Precision-drilled custom tubing and tubular components are used in medical devices, aerospace applications, nuclearpower plants, industrial manufacturing plants, high temperature furnaces and many other designs. When it comes to tubing and tubular components, concentric, seamless precision tubing is often chosen for its added reliability, rotational stability, strength and increased useful life. Unlike welded tubing, seamless tubing is able to handle high pressure evenly, provides uniform fatigue properties and often reduces the frequency for inspections in high stakes uses. Tube Hollows International specializes in manufacturing highly concentric tube hollows that meet critical design tolerances. The company machines ultra-high concentricity seamless precision tubing in the most challenging alloys, using gun drilling, trepanning, honing and other technologies. I sat down with Tube Hollows to draw from their expertise and gain a greater understanding of the benefits of concentricity. Tube Hollows’ Director of Business Development Alex Miller explained that when engineers define the component part and tubing requirements of complex engineering projects, they often must strike a balance between design specifications, cost, safety, and quality concerns. The concentricity needs of a project can be determined by assessing how the part will function in its end use, whether or not the part will interact with other parts and the environmental factors influencing tolerances for the part. According to Tube Hollows and leading engineering professionals, concentricity in …
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