Medical Device Regulatory Affairs and Quality Management Outsourcing

In a perfect world, your regulatory compliance workload would remain steady and your best QA/RA staff members would stay with your company for the long haul. As you know, that’s not world we live in. Experienced medical device regulatory professionals are in high demand and ever-evolving requirements are pushing QA/RA departments to the limit. NAMSA’s experienced consulting team offers a flexible option to even out your workload or address a critical project so you stay on schedule and in compliance.

Three Ways NAMSA Can Assist

1. RA/QA Staff Augmentation – If a senior member of your QA or RA team has recently left your company and you need to maintain continuity of the work they were performing, we can plug that hole quickly. We have a deep pool of highly experienced quality and regulatory consultants that can step in to help you fulfill your ongoing regulatory obligations until a replacement can be hired. If desired, our consultant can also stay on to train your new hire so they hit the ground running and you remain focused on the work your team needs to accomplish. Whether you need a Medical Writer or a Regulatory Strategist, our team is avaiable to help balance your workload or undertake special projects that require niche skills.
2. Special RA/QA Projects – Often, companies come to us because they have a short-term project to tackle but don’t want to add full-time staff to the payroll. That’s a smart approach when you need specific expertise in a hurry, but you don’t need it forever. Whether you need dozens of Clinical Evaluation Reports (CER) reviewed quickly, QMS facility audits, or help mitigating findings after a recent FDA inspection or Notified Body audit, our team is available to jump in and help.
3. Functional Areas – Smaller device manufacturers often find it to be more cost effective to outsource most regulatory or QMS compliance functions, especially before their first device gains regulatory approval. Common ways we help companies of all sizes include ISO 13485 and FDA QMSR setup and maintenance, medical device registration, medical writing, and postmarket surveillance.

Full Strategic Support

If you are bringing a new device to market and need a full-service strategic solution, consider checking out our APEX PROGRAM. Our strategic solution is designed to guide smaller companies through all phases of the device approval process, from initial regulatory strategy and preclinical studies to clinical trials and device registration. Companies that have participated in the APEX PROGRAM have considerably shortened their time to market and saved millions of dollars.

Why Work With NAMSA?

The advantage of working directly with us is that unlike a generalist staffing agency, our consultants specialize in medical devices. Once we fully understand your needs, we will pair you with a consultant ideally suited to meet your short-term needs, whether it’s for ten days or ten months. Because our team members are so experienced, the overall cost of outsourcing to address a specific staffing, project, or functional challenge can be very cost-effective. No training required!