Marcia Kelley's Contact Details

Marcia Kelley's Company Details

AlvaMed, LLC.

Needham, MA, US • 20 - 49 Employees
Medical Equipment

AlvaMed is a medical device consulting and outsourcing organization. We provide the full breadth of compliance services to our clients: quality assurance, quality system development, regulatory approval and compliance, and CRO/clinical management services.AlvaMed is an industry leader in medical device consulting and is comprised of technically savvy quality, clinical and regulatory professionals with a broad range of complementary skills. The flexibility within our team allows us to quickly adapt our level of support to your changing needs or shift focus as you hire your own internal resources. We strive to build long term relationships with our clients by listening to them and then providing "right sized" services and solutions.Regulatory, clinical and quality compliance consulting services to the lifescience industry, including:* US FDA submissions; * CE Marking and Technical File updates with EU notified bodies;* ISO 13485, MDSAP and other certification assistance;* Audits; * Due diligence support.* Quality system development, documentation and remediation;* Product labeling and documentation support;* Unique Device Identifier (UDI) support;* IEC 60601 support;* Audit response, clinical evaluation reporting, complaints and CAPA remediation;* Clinical trial protocol creation, study oversight, site initiation, CRA management, closeout and reporting;* Postmarket surveillance system assessment and strategy.