APRIL 2018 INDUSTRY NEWS
A timeline to adopt medical device QMS (and why you need to act now)
“To be blunt, if your company has put off doing anything about ISO 13485:2016, you need to act immediately. We’re in the window where there is less than a year until you need to be ISO 13485:2016 certified. There is no extension. ISO won’t accept any excuses – this has been published for at least two years now. I know you’re busy and there’s a lot going on, but I’ve heard some anecdotal evidence to suggest that perhaps as little as only 2 percent of US medical device companies have their certification done already. This came from an auditor at one of the largest notified bodies. That implies that a lot of companies are in the same position – they might be ISO certified right now, but they haven’t made the switch to get updated.”
Greenlight Guru and PathWise Announces Joint Training Event in Switzerland
“PathWise is well respected in the medical device, pharmaceutical and biotech regulatory consulting and training industry,” says Greenlight Guru co-founder and CEO David DeRam. “This partnership will allow us to combine our purpose built quality management software platform with PathWise’s on-site training curriculum to serve a quickly developing market.” The relationship will consist ofon-site training to provide education and guidance on the rapidly evolving domestic European Union medical device regulatory environments, including MDR 2017/745 and the coming MDR 2020 implementation deadline. The training will be hosted in Basel, Switzerland June 27-29.”
Health Canada Eases Requirements for MDSAP Transition
“In response to medical device manufacturers facing audit scheduling challenges, Health Canada announced Friday a policy turnabout in requirements for transitioning to the Medical Device Single Audit Program (MDSAP). Manufacturers will be required to submit MDSAP certificates by 31 December 2018 to legally sell devices in the Canada market. However, Health Canada has now decided not to take enforcement actions against manufacturers without these certificates if they demonstrate they have undergone a MDSAP audit by the same deadline.”
View the PathWise Webinar on the MDSAP program HERE!
FDA Medical Device Safety Action Plan Spotlights Cybersecurity
“The Food and Drug Administration (FDA) released an 18-page document Tuesday designed to help protect patients from the risks of unsafe medical devices in an increasingly interconnected world. The document, titled “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health,” outlines how the FDA intends to guard against current and future threats, both in the physical world and online. Like computers and the networks they operate in, medical devices can be vulnerable to security breaches. Exploitation of device vulnerabilities could threaten the health and safety of patients,” FDA Commissioner Scott Gottlieb said in a statement.”
With just one year to go until the UK withdraws from the EU, industry says regulatory repercussions for drugmakers are still unclear.
MARCH 2018 INDUSTRY NEWS
Mobile Robots in the Pharmaceutical Industry
Medical technology requires a special degree of efficiency and precision in the production of parts intended for medical purposes. At the same time, the industry faces increasing demands due to the competition from the global market and increasing customer expectations. To meet the market demands, it is vital to keep producing high-quality products with flexibility and within a short delivery window. Autonomous mobile robots (AMRs) are frequently used precisely for this purpose, as the dynamic and flexible technology enables companies to automate their internal material transportation in an efficient and cost-effective way. To succeed, manufacturers need to use their resources efficiently and design reliable operational processes that support their production.
MDSAP Certification Route Extended to Brazilian, South American Medical Device Companies
Brazilian medical device market regulator ANVISA has officially extended applicability of the Medical Device Single Audit Program (MDSAP) to domestic manufacturers as well as other companies based in South America. According to RDC 217.2018 (link in Portuguese), the MDSAP good manufacturing practice certification route is now open to medical device manufacturers based in Brazil, as well as to manufacturers based in South American countries belonging to the MERCOSUL trade group: Argentina, Paraguay and Uruguay.
View the PathWise Webinar on the MDSAP program HERE!
Proactive Quality Systems: FDA Has Made Them A Priority — Has Your Organization?
FDA’s traditional compliance requirements establish a uniform quality system framework, but do not ensure device quality across the ecosystem. Furthermore, a compliance audit will tell a manufacturer whether the system they have established is compliant with current regulations but offers no insight into how they might improve the device, the system, or the development process.Taking predictive and proactive measures to improve quality can have far-reaching effects – from more efficient resource allocation to decreased probability of a recall.
Medical device regulations: Here’s what manufacturers need from their vendors
“The E.U. MDR has finally been adopted after five years of planning and more than 20 years of recognizing an outdated system. New innovation in medical device design was certainly not the only factor for this change; however, with the system being in place for decades, it was time to stop amending and do a complete overhaul. Improved ways to regulate new technology was definitely a factor.”
Interested in more information about the MDR 2017/745? Attend the upcoming PathWise public training course, covering the classification criteria, new requirements, how to set up training and education for preparation, and several other items.
Worldwide Contract Pharmaceutical Manufacturing Market | Expected to reach Healthy CAGR | Forecast till 2025
Pharmaceutical manufacturing market includes outsourcing of manufacturing services by pharmaceutical players to contract manufacturing organizations (CMO). CMOs provide manufacturing services for both Active Pharmaceutical Ingredients (APIs) and Finished Dosage Formulations (FDFs). Top-down and bottom-up approaches were used to validate the size of the global market and estimate the size of various other dependent submarkets. Major players in the market were identified through secondary research and their market revenues were determined through primary and secondary research.”
FEBRUARY 2018 INDUSTRY NEWS
Regulatory challenges top list of concerns of medtech professionals in annual survey
“he survey of medtech professionals that regulatory consultancy Emergo (Austin, TX) conducts each year is a good gauge of the mood of the global medical device industry as it heads into a new year. Typically, there are no dramatic shifts in attitudes and perceptions from one year to the next—progress and change tend to be incremental in the medtech sector—but there is movement on the margins that can be instructive.”
CDER in warning letter frenzy as pharma struggles with quality control
“Warning letters from the Food and Drug Administration’s Center for Drug Evaluation and Research spiked last year as drugmakers struggled to maintain quality control at their manufacturing sites, according to a new report from PwC. Though the FDA actually issued 22% fewer warning letters overall in 2017 versus 2016, the number coming from its CDER unit rose 35% for a total of 85.
PwC Analysis: Fewer New Regulations in 2017, But No Major Course Change at FDA
“While 2017 was a standout year for the US Food and Drug Administration (FDA), many aspects of the agency’s work were business as usual in a year that saw a new president and new leadership at FDA…And according to PwC’s analysis, 2017 saw the lowest number of economically significant new regulations in the last 20 years. The agency also promulgated fewer new and proposed regulations than in all but four of those years, though the regulation totals included FDA’s work in food, devices and other industries outside of biopharma.”