Browse by Editorial Category
Browse by Edition Date

September 2017

Skip Navigation Links.
Expand Applying TechnologyApplying Technology
Expand Energy ManufacturingEnergy Manufacturing
Collapse Current NewsCurrent News
A3 Fall Conferences
AIMS Metrology Achieves ISOIEC 170252005 Accreditation for Calibration
Amada Miyachi America Receives ISO 9001 Certification
American Punch Begins Construction on Major Plant Expansion
Products Streamline Compliance with New MDR
BARTON International Triples Capacity of Warehouse
BLM GROUP USA Opens New Headquarters and Tech Center
Mobile Press Brake
Welding Technology Seminar Fall 2017-Spring 2018
Caron Engineering Integrator Gains Territory in the South
Cimquest Advanced Manufacturing Expo Oct. 18-19
Get the Team on Board
Company Expands CMM Sales with New Distributor
U.S. Cutting Tool 2017 YTD Consumption Up
DENSO Foundations 2017
Doosan Machine Tools America Partners with 5ME Cryogenics
End-to-End Material Flow Solutions
Emuge to Hold Joint-Open House on September 14
Rolls-Royce Supplier Establishes Manufacturing Center in the Richmond Region
Fives Opens New Technology Center in the U.S.
Ganesh Machinery Open House Gen Fest 2017
GF Machining Solutions System 3R Celebrates 50 Years of Precision
Curve Data Support for Simulation
500 and#176;F Truck Oven
Heimatec Named North American Distributor for Tecnicrafts
HFOMidwest and SCTD Celebrate Grand Opening of HTEC Machine Lab
Haas Oktoberfest is Coming to the Midwest in September
Haas Oktoberfest Returns to New England September 20th
Machinery Source Named HYUNDAI WIAs Exclusive Dealer for Illinois
JBM Technologies Fall Open House
Tips for Taming Tinnitus and Better Shop Hearing Protection
Operation Next to Prepare Future Veterans for Civilian Careers
New Pump Reclaims Coolant from Chip Hoppers
GARR TOOL Partners with MachiningCloud
G.W. Schultz Available on MachiningCloud
Mastercams MachiningCloud Connection is Now Available
TaeguTec Now Available on MachiningCloud
Mazak iSMART Factory Initiative Spreads to Japan Plant
MC Machinery Celebrates Grand Opening of New Headquarters
Methods Machine Tools to Host MetalStorm 2017 October 4-5
DESTACO named a Vendor of the Year by MSC Industrial Supply
MSCI Economic Summit Forecast 2018
Murata Machinery USA to Host Technology Showcase
Nasmyth Group Opens New Metal Treatments Facility
Production of Security Chips in NXPs U.S. Manufacturing Facilities
Optomec Announces NASA Award for Adaptive Laser Sintering System
Productivity Inc. Named as Diamond Level Distributor for Desktop Metal
Pyramid Imaging Opens FPGA Competence Center
Keynote Speakers to Present at the Quality Show 2017
SME and Stratasys Announce Winners of the 2017 SkillsUSA Additive Manufacturing Competition
In-Process Correction Technology for Hybrid Metal 3-D Printer
TOYOTECH 2017 September 13-14
Expansion of SlittingEdging Operations
U.S. Manufacturing Technology Orders Continue to Gain Strength
UTRC Unveils Expanded Innovation Hub
Vision Engineering and Luxo Corporation Form Partnership
WIMTS Show Adds 3M Exhibit and Next Generation Manufacturing Summit to 2017 Event
Expand People In The NewsPeople In The News
Expand Quality ControlQuality Control
Expand WeldingWelding
Expand WorkholdingWorkholding

show all editions →

Click here to watch Tutorial Videos >

Products Streamline Compliance with New MDR



The new European Medical Device Regulation (MDR) EU 2017/745 lays down rules concerning the placing on the market of medical devices for human use. As part of a global harmonization effort, many aspects of the new MDR is aligned with requirements noted in the U.S. FDA CFRs, as well as the recent release of ISO 13485:2016, an international standard governing medical device quality man agement systems.

The MDR places a greater emphasis on clinical evaluation and clinical investigations as part of the conformity assessment process. Current CE marked products will not be "grandfathered" and will need to meet the requirements of the new regulation. Thus, many companies will face a significant challenge to provide the required clinical safety and performance information for previously CE marked devices. Companies will also have the added challenge to update their quality management system to conform with the new standards and regulations. In order to address these industry needs, A.P. Lyon developed a series of clinical evaluation and quality system products designed for medical device manufacturers to simplify the transition.

A.P. Lyon released multiple procedures that comply with the MDR, ISO 13485:2016 and the FDA QSR to ensure manufacturers comply with the new requirements. A.P. Lyon also created a comprehensive ISO 13485:2016 quality management system that governs multiple aspects of medical device design, development and pre- and post-commercialization activities. The A.P. Lyon quality system products harmonize the global medical device requirements in an intuitive, user-friendly manner that simplifies quality system implementation / modification and in a manner that promotes its continued use.

Incorporating risk management throughout all aspects of medical device manufacture and commercialization is a common theme in the recent changes to various standards and regulations. The risk management system that A.P. Lyon has incorporated into its system products is aligned with and reflected in the clinical evaluation process for a medical device, including the clinical risks to be addressed as part of clinical investigations and clinical evaluation and post-market clinical follow up. "The content of A.P. Lyon risk management procedures provides clear and precise instruction on device characterization, risk assessment, risk-benefit analysis and all risk related activities," said a company spokesperson.

New unique device identification (UDI) requirements have been incorporated into both U.S. and European regulations. In order to help companies address the new global requirements associated with the traceability of devices by means of a UDI system, a comprehensive procedure based on international guidance was created and should help manufacturers adhere to the new requirements and provide instruction on both formatting UDIs and for data entry into FDA GUDID and EUDAMED systems.

A.P. Lyon's quality system procedures help manufacturers continue to meet their previous critical obligations that were made part of the MDD and FDA CFRs, such as clinical evaluation reports (CER), medical device reports or vigilance reporting, post-market surveillance and risk management process, ensuring these activities are properly carried out within the manufacturer's organization.

For more information contact:

A.P. LYON

120 Old Colonial Dr., Suite 4

Gardner, MA 01440

978-238-1245

info@aplyon.com

www.aplyon.com

< back