“Vigorous approaches to chemicals’ safety and sustainability will drive company and brand differentiation,” says Sue Bullock
Sue Bullock joined the consultancy earlier this year to lead the chemical compliance, stewardship and sustainability team. She notes the focus on ‘safer’ products has been...
“Vigorous approaches to chemicals’ safety and sustainability will drive company and brand differentiation,” says Sue Bullock
Sue Bullock joined the consultancy earlier this year to lead the chemical compliance, stewardship and sustainability team. She notes the focus on ‘safer’ products has been...
When should you contact FDA about a new medical device?
Approaching FDA ahead of formal premarket submission can make the regulatory process smoother for medical devices. But...
Six steps to obtaining 510(k) premarket clearance for medical devices
What’s the best way to go about obtaining FDA authorization to market a medical device? This is the million-dollar...
Video: An overview of FDA’s premarket regulation of medical devices
FDA’s legal and regulatory framework The definition of a medical device FDA’s risk-based classification of a device...
How to sharpen up FDA medical device submissions and meetings
When medical device companies make an application or submission to the Food and Drug Administration (FDA) a lot of...
Medical device 510(k) premarket notifications: sometimes slow and steady wins the race
As any medical device manufacturer knows, obtaining 510(k) clearance can represent a significant milestone in the...
Professionals
Our regulatory specialists and scientists address all aspects of product registration and ongoing compliance. Read more about the individuals who make up our multi-disciplinary teams.
