Spectrum appoints Medical Devices expert Karen Cornelius

HORSHAM, U.K. - Oct. 23, 2014 - PRLog -- Karen has worked in the healthcare industry for more than twenty years, initially in the laboratory as a research scientist and then moving into Phase I/II pharmaceutical clinical research. Subsequently Karen managed clinical trials involving medical devices and combination products. For the last 10 years she has gained in-depth experience of product development under design control as well as setting up systems to meet vigilance and clinical evaluation requirements. Karen has defined regulatory strategy and carried out submissions for medical devices and combination products in the EU, USA, Canada, Australia and other territories internationally.

“I am delighted to join Spectrum’s regulatory affairs team and promote their medical device and device/drug combination service offerings”, said Karen Cornelius. “We can help clients to negotiate the regulatory issues and clinical trial challenges when taking a device or combination product to market.”

“We are very pleased to welcome Karen and the knowledge that she brings to Spectrum” added Dr Angela Gisby, Managing Director. “I know that her expertise in regulatory strategy and clinical development and medical devices will be invaluable.”

About Spectrum

Spectrum Regulatory Solutions was established in 2005 and provides a full-service consultancy to the healthcare industry. Uniquely, this comprises a suite of services which support manufacturers both during the run-up to obtaining marketing approval, and in post-marketing activities. These services include regulatory affairs, medical writing, safety and vigilance, market access, readability, quality assurance and compliance. Spectrum’s experience covers both medicinal products – pharmaceutical, biological, OTC, cosmetics, herbal and nutritional – and medical devices.