AlvaMed has recently started work with 4 new clients – “insourcing” our quality, regulatory and clinical support. Avoiding the pressure to hire additional staff, our clients benefit by immediately adding compliance expertise to their team and adopting our tools and systems that have been audited multiple times. AlvaMed has:
- Achieved ISO 13485 certification making it easy to bring us on as a critical supplier
- Added Part 11 compliant document management to enable the adoption of electronic signatures and electronic record management,
- Hired addition staff to provide the right level of support in terms of seniority and function; and,
- Added online data storage and electronic signature applications.
This service offering is a longer term commitment (6 months or more) where we develop and maintain our client’s quality system and work closely with our client acting as their quality, regulatory and clinical affairs functions. Our clients benefit from our tools and experience in our daily involvement with their team. Our service allows our client to:
- Delay hiring staff for these functions until later in the company’s development – when full-time support is required; and,
- Reduce the pressure and anxiety of hiring new employees – allowing our clients more time to find, interview and select the best candidates to join their team.
If you are a small company that has recently prototyped a new product and are now wondering how build a new quality system and address your compliance needs, contact AlvaMed.