RSP Systems is awarded the ISO 13485:2016 Certification from LRQA, an Important Milestone towards CE Marking and Product Launch

The procedure of implementing RSP System’s Quality Management System began in late 2016 with the building of a strong QA and Clinical Trial team. This effort has gradually strengthened, and the newly awarded certification is the achievement of the first important milestone for the program, which has...... read more

Domestic medical device makers accuse the govt of favouring MNCs

Indian medical device manufacturers have accused the government of favoring foreign multinational medical technology companies by imposing restrictive conditions in procurement tenders. Association of Indian Medical Device Industry (AiMeD), a representative body of domestic medical device makers all...... read more

CE Certification Opens EU Market to Six Cortec MCI Concrete Protection Products

Cortec Corporation is now certified to use CE marking on six Migrating Corrosion Inhibitor (MCI) products for the protection and repair of concrete structures: MCI CorrVerter, MCI-2018, MCI-2019, MCI-2021, MCI Architectural Coating, and MCI Wall Defense. The marking certifies that Cortec meets the 2...... read more

Vesalio Declares NeVa Stroke Treatment Product CE Mark Certification

Vesalio declares the CE Mark certification of its first product line, the proprietary NeVa neurothrombectomy platform for the treatment of strokes. Developed by a team of physicians that treat stroke, the NeVa mechanical thrombectomy technology was designed to progress “first pass” success, by e...... read more

Adhesys Medical gets CE mark for its topical skin adhesive for surgical use

Adhesys Medical, a surgical adhesive company, said it has received a CE mark for its Mar-Cutis Flix topical skin adhesive for surgical use. The adhesive is a polyurethane-based technology the company said is an inventive alternative to traditional wound closing techniques that features bonding s...... read more

Arco warns of carcinogenic dangers found in some safety gloves

Safety product manufacturer Arco is warning tradespeople about the dangers associated with some leather safety gloves presently available on the market. Following market surveillance carried out over two years ago on a number of EC type approved and CE marked leather safety gloves, Arco says tha...... read more

Check-Cap Reports Fourth Quarter and Full Year 2017 Financial Results

Initiated an EU post approval study using C-Scan system Version 3 (formerly referred to as Advanced C-Scan system), which incorporates the latest algorithms and system optimization and tailors scanning of the colon to the patient's natural colonic movements to maximize the amount of the colon that i...... read more

RevMedx receives CE Mark for XSTAT injectable hemostatic devices.

RevMedx, Inc., a leader in inventive devices that control severe bleeding, today declared it has received CE (Conformité Européenne) Mark Certification for the XSTAT 30 and XSTAT 12 hemostatic devices in Europe.  Unlike traditional wound treatments that may take several minutes to be actual, XSTAT c...... read more

CE Certificate Marks another Milestone for Bespoke Light box Manufacturer

Huddersfield-headquartered graphic display specialist Leach has recorded a new industry milestone by becoming one of the first UK suppliers to protected CE certification for its renowned light boxes. 20 configurations of the team’s iconic LED-lit products have all been separately assessed as par...... read more

Energous (WATT) Announces CE Marking Certification for its WattUp near Field Wireless Charging Technology

Energous Corporation (NASDAQ: WATT) declared it has protected a CE Marking for its WattUp Near Field wireless charging technology operating in the 900 MHz band, a certification that covers products sold within the European Economic Area (EEA). The WattUp near Field technology permits for contact-bas...... read more

MFG Announces ISO 9001:2015 Certification

MFG Chemical, Inc., is pleased to announce it has been awarded ISO 9001:2015 certification by DQS for its Quality Management Systems for the contract manufacturing of specialty chemicals. The award is a testament to the ever increasing commitment by the company's management and to the foundation cre...... read more

National Petrochemical Industrial Company achieves first with ABS certification

ABS Quality Evaluations, Inc., a subsidiary of ABS Group, has awarded the National Petrochemical Industrial Company of Saudi Arabia the first issued RC 14001:2015 certificate globally. The RC14001 Technical Specification (2015 edition) combines elements of the American Chemistry Council's Respon...... read more

IPC Awards ISC Engineering, LLC IPC/WHMA-A-620 Qualified Manufacturers Listing (QML) certification.

IPC’s Validation Services Program has awarded an IPC/WHMA-A-620 Qualified Manufacturers Listing (QML) to ISC Engineering, LLC’s Chino, California. facility. The ISC Engineering facility successfully completed an intensive audit to IPC/WHMA-A-620, Requirements and Acceptance for Cable and Wire Ha...... read more

NaviENT Navigation System gets CE Mark

ClaroNav Kolahi Inc. (CKI) announced today that it has received CE Certificate approval for the commercial sale of its NaviENT cranial and ENT navigation system in Europe. Over the coming months the company will offer the product for sale to hospitals, clinics and offices performing endoscopic sinus...... read more

Barton Fabrications accredited to CE Mark silos

Barton Fabrications, the UK’s largest manufacturer of aluminium storage silos, has achieved accreditation to CE mark its vessels to EN 1090: this ensures compliance with the latest Construction Products Regulations. The standard gives customers the confidence that the silos, pipework, gantries and l...... read more

Creavo's portable emergency room heart scanner scores CE mark

Diagnostics player Creavo Medical picked up a CE marking certificate for its battery-powered, portable scanner to help emergency room staff quickly assess heart problems in patients with chest pain. The device, Vitalscan, is Coventry, U.K.-based Creavo’s first product. The noninvasive scan takes...... read more

Neovasc (NVCN) Receives Approval to Initiate TIARA II CE Mark Study in Italy

Neovasc Inc. received both regulatory and ethics committee approval to initiate the Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA II) in Italy. TIARA II is a 115 patient, non-randomized, prospective clinical study evaluating the safety and performance of the Tiara™ Transcatheter Mitral ...... read more

Exact Imaging Receives CE Mark Approval for its ExactVu™ Micro-Ultrasound System for Prostate Imaging and Biopsy

Exact Imaging , the world's leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, today announced that it has received CE Marking approval for its ExactVu™ micro-ultrasound system for prostate imaging and biopsy guidance. "We are t...... read more

CENTURY PCB Taiwan Now Certified to ISO 13485

CENTURY PC Board Ltd Taiwan has received the ISO 13485 certification for the manufacture of printed circuit boards (PCB) for the medical industry.  "ISO 13485 is simply the affirmation of the processes we have built in-house supporting our growing medical segment. It is a true reflection of the ...... read more

US, EU Look to Mutually Recognize GMP Inspections by January 2017

The US and EU say they have made more progress on harmonizing good manufacturing practice (GMP) inspections and could reach a deal by January 2017, according to a report on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP). A major sticking point for bo...... read more

Food Companies Mean Business When it Comes to Foodborne Illness

Fortunately, food companies can now avail themselves of a wide range of excellent, on-line and in-person food safety training courses and resources, offered through public agencies and private sector experts such as SCS. Additionally, companies are undergoing third-party audits and ISO Certification...... read more

RigWorld gets 5 nominations for 2016 Ghana Oil and Gas Awards

Rigworld International Services Limited has once again gained recognition for its hard work and dedication in the industry. Ghana’s vibrant and the only International Organization for Standardization (ISO certifications), and (ISO 14001: 2015, ISO 9001:2015 and OHSAS 18001:2007 certified upstream se...... read more

Target Hydraulics DC Power Units Pass CE Certification from 2016

Target Hydraulics , a global manufacturer and supplier of hydraulic cartridge valves, valve manifolds and power pack units; is pleased to announce that the hydraulic DC power unit has successfully been evaluated for the European CE Marking compliance.  "Passing CE certification requirement is a ...... read more

Aquatic Demonstrates Continued Commitment to HSEQ

Aquatic Engineering & Construction Ltd, an Acteon company, has successfully completed re-certification to ISO 9001 CERTIFICATION ; ISO Certification14001 & OHSAS 18001 certification , demonstrating a commitment to quality; the environment and health & safety. The Lloyds Register Quality Assurance (L...... read more

OMA Emirates adds feather in cap with ISO 9001:2015 Quality Management Certification

OMA Emirates, a provider of cutting edge technology solutions for the payment industry announced the achievement for its ISO CERTIFICATION 9001: 2015 Quality Management System across the organization. It reiterates the company’s commitment to provide internationally recognized quality and high custo...... read more

eKuber Ventures, Inc. Appraised At CMMI Dev Level 3 And Awarded ISO 9001:2015 Certificate

eKuber Ventures, Inc. today announced that it has been appraised at level 3 of the CMMI Institute's Capability Maturity Model Integration (CMMI)®. The CMMI appraisal was performed by Quality Point Integrating Systems LLC, while the ISO 9001:2015 Management System Certificate was awarded by the GMS R...... read more

Global Marine Upgrades to ISO 9001:2015 Accreditation

Global Marine Systems Limited has announced that it has succeeded in upgrading its ISO 9001 certification to the new International Quality Standard ISO 9001:2015. Demonstrating its continued commitment to being at the forefront of developments in this discipline, Global Marine is one of the first co...... read more

Government to give up to 33 per cent equity share of NDL to private sector

The government is preparing to give up to 33 per cent equity share of Nepal Drugs Ltd (NDL) to private sector. The state-owned drug producer is on verge of revival from its seven years of defunct state after the cabinet, two weeks ago, approved proposal of Ministry of Industry to restore NDL and...... read more

IMI Mexico Achieves ISO 14001 Recertification

September 14, 2016, Laguna, Philippines—Integrated Micro-Electronics Inc. (IMI), one of the leading worldwide providers of electronics manufacturing services (EMS) and power semiconductor assembly and test services, today announced that its subsidiary IMI Mexico recently achieved ISO14001 recertific...... read more

CE Mark-Consultancy-CE Certification- CE Consultants- CE Mark

CE Mark is the manufacturers guarantee that their product observes to all the relevant directives and standards that are used to determine compliance. The advantage of the CE mark is that CE Certification safeguards free movement of goods throughout Europe and proves that the product complies with t...... read more

CE Consultants Dubai CE Mark Consultancy in Dubai

he CE marking shall be affixed only by the manufacturer or his appointed representative. CE marking shall be only mark which attests the conformity of the product with the applicable requirement of the relevant Community harmonisation legislation providing for its affixing. CE Marking consultants, C...... read more

What is CE Marking (CE mark)

The CE marking is the manufacturer declaration that the product meets the requirements of the applicable EC directives. The actual words signified by "CE" have been undecided. It is often taken to be an abbreviation of Conformité Européenne, meaning "European Conformity". CE mark, CE marking, CE req...... read more

CE Marking Certification in UAE

The CE mark signifies a product’s compliance with applicable EU legislation and so strategically endorses the hassle-free and flexible movement of products within the European business market. CE Mark approval, CE testing and CE mark requirements CE Marking is about affixing a product conformity sym...... read more

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