Category Archives: Regulatory compliance

6 Deadly Mistakes That Destroy Start-Up Medical Diagnostic Laboratories

Start up medical diagnostic laboratory

We have helped many entrepreneurs start their own labs. Most found success and have been growing; some reached a certain size and stabilized. Others never really got off the ground. The successful labs each found their own version of success. However, the labs that failed did so in several predictable ways. If your lab can […]

29 questions to ask your consultant before hiring them – Part 1

Consultant interview questions

Consultant’s credentials, knowledge and experience 1. What is your area of expertise? To solve a problem, you have to define it first. Once you define the problem, you should clearly understand the exact area of expertise needed to achieve a solution. For example, you need a skin doctor (and not a general practitioner) to treat […]

Case study: achieving ISO-15189:2012 accreditation to perform COVID-19 testing

Medical diagnostic laboratory business consulting case study

Client profile: A mid-size medical diagnostic laboratory in Jamaica, which prior to seeking consultation was performing only clinical chemistry, immunoassay, hematology and microbiology tests. Reason for consultation: Achieving industry certification and regulatory compliance. The client felt unprepared for the upcoming JANAAC inspection for ISO-15189:2012 accreditation. This accreditation was crucial for becoming qualified to perform COVID-19 […]