Frequently Asked Questions

How do we deliver?

Medpoint has been providing exceptional consulting and talent acquisition services to our customers since 2002.

Does your staff have experience in the life sciences industry?

Yes! Our leadership team has more than 125 years of experience in the life sciences industry – we understand your challenges, needs, and requirements.

What industries do you support?

Our Medpoint team supports a diverse portfolio of clients including the largest global healthcare manufacturers and early-stage medtech startups. Our core customers are pharmaceutical, medical device, and biotechnology manufacturers and their suppliers.

Can you help us find good candidates for direct hire?

Yes we can! We have certified recruiters on our team. Medpoint has placed outstanding candidates in client roles including executive management level to individual technical experts across disciplines and throughout the life science industries.

What types of auditing services do you provide?

Our global auditing and gap assessment services include mock-FDA and Bioresearch Monitoring (BIMO) inspections, internal audits, supplier audits, quality surveys and more. These audit services can be conducted on site or virtually, and in local languages if necessary. Our global team of experts delivers effective and timely results. We are very scalable and can accommodate volumes from single audits to hundreds of audits per year.

What standards and regulations can Medpoint audit against?

We can conduct gap assessments and audits against most US and international standards including 21CFR (various parts), ISO 9001, ISO 13485, ISO 14971, MDSAP, EUMDR, IVDR and many others.

What is your value proposition?

You have a business to operate – let Medpoint help you where you have resource gaps. Medpoint’s global network of professionals provides local resources to support our clients’ requirements to ensure the safety and efficacy of their respective products and services. Our in-country and in-region resources help you avoid lost time, reduce travel and other expenses, while achieving milestones and delivering professional reports and guidance on time and in budget. We know our customers like to do business with people they like and trust – and we have a 20+ year track record of repeat customers.

Do you provide both long- and short-term resourcing?

Yes, some Medpoint consultants have remained on assignment with individual customers for years while other Medpoint professionals have provided client consultantation for a few hours to advise on specific scenarios – and everything in between.

Where are your resources located?

We have professionals located in many countries and regions around the world, including North America, Central America, South America, Europe, Asia Pacific, Africa and Australia. If you have a global need, Medpoint will identify a qualified resource with appropriate language skills and proximity to support your efforts.

Does Medpoint have a certified Quality Management System?

Yes! Medpoint has a QMS certified to ISO 9001:2015. Our certification body is SGS and our initial certification dates to January 2018.

How long does it take Medpoint to onboard a new customer?

Our onboarding process is designed to be flexible and efficient. We can get a new customer onboarded in 2-3 days. Frequently the new customer’s internal procedures require a longer lead time to complete. We can typically provide a quote within 1 business day following a brief scoping call.

Can I be involved in the consultant selection process?

That is up to you and you can be involved as you wish! Some customers give us requirements and ask us to assign an appropriate resource, others want to interview and pre-approve consultants. We will accommodate your processes.

How do you monitor and control your resources?

Our QMS includes procedures for the selection, onboarding, and monitoring of our consultants – this includes interviews, verification of qualifications and training, background checks, reference checks, evaluations, feedback, and recognition. During client engagements, Medpoint also assigns a project coordinator to monitor the interaction, project progression, and provide support for client communications and reporting.

Can Medpoint help train my team?

Yes, Medpoint can develop and deliver training an any quality or regulatory subject matter – according to your specific needs. Training can be delivered on-site or remotely. Examples of recent training subjects that we have delivered for our clients include Risk Management, ISO 13485:2016, internal auditing, and What to Expect in an FDA inspection.

Contact Us Today

Contact us today to discuss your needs and discover the difference our world-class expertise will make for your business.