Intertek, the leading quality solutions provider to industries worldwide, announces a series of complimentary webinars that will began on 8 August and will continue through November.
The theme is ‘Navigating Regulatory Compliance within the Medical Device Industry’, with each webinar addressing a unique aspect of the compliance process for medical devices, management systems, chemicals, and pharmaceuticals.
Medical devices are tested to some of the most complex product safety standards in the manufacturing industry and have a high first-time failure rate that can be reduced by understanding and applying the applicable standards early in the product development cycle.
Additionally, most countries require medical device manufacturers to have a third-party audited and certified management system in place before selling any medical product. Facing the challenges of rapidly evolving regulations and increased regulatory scrutiny in the face of significant internal restructuring and mounting budgetary constraints, companies are coming to the realisation that designing and manufacturing their product for regulatory compliance is critical to the development of innovative healthcare solutions. This, combined with an initial upfront conformance plan, will help to ensure products are brought to market on schedule.
"Critical decisions made at the beginning of a project can greatly impact a product’s time to market," says Pam Streed, vice- president of Intertek’s Electrical Group.
"We have helped leading device manufacturers get to market on time and within budget by conducting analysis and pre-compliance reviews in the earliest stages of design. Together, we can develop a compliance roadmap with a company’s specific goals in mind, helping the client to achieve regulatory compliance their first time through the process."
To better position medical companies to excel in this rapidly evolving regulatory market, Intertek’s webinar series will cover these topics:
- ISO 13485 Certification and Conformity Assessment to The Medical Device Directive, August 8, 2013
- Converting a Legacy Device to Wireless, August 26, 2013
- Common Pitfalls & Best Practices for 3rd Edition Risk Management, October 1, 2013
- Home Healthcare, 60601-1-11 Series Review, October 24, 2013
- The First Amendment to the Third Edition – Simplified, October 30, 2013
- All You Need to Know About RoHS 2, November 6, 2013
- Navigating Risk for 61010-1, Third Edition, November 13, 2013
The November 6 session focusing on the Restriction of Hazardous Substances Directive (2011/65/EU), also known as RoHS 2, will highlight compliance requirements going into effect July 22, 2014 for medical devices. With more than one third of their revenue coming from the European market, medical device companies are challenged to compile appropriate technical and process documentation as evidence for RoHS 2 compliance. Intertek’s service portfolio provides support for manufacturers throughout their compliance efforts, including a gap analysis of their process, compilation of compliance documentation, analytical testing, and more.
"This webinar series represents Intertek’s core value to educate our medical device clients on evolving regulatory requirements for chemical safety, environmental compliance, electrical safety, performance, and global market entry," says Dr Ruud Overbeek, Global vice-president of Intertek Health, Environmental, and Regulatory Services. "Through the breadth of capabilities and resources offered through One Intertek, we succeed in delivering the full-service solutions that our clients require."
To learn more about Intertek’s webinar series, visit: http://www.intertek.com/medical/events/one-intertek-webinar-series.