BJD Tech Writing offers writing/editing services for the life sciences including biotech and medical devices including:

• user manuals/Instructions For Use (IFUs)
• labeling for medical devices
• labeling for in vitro diagnostics (IVDs)
• SOPs and work instructions
• Verification and validation reports

My name is Bernard Delacruz. After earning my PhD in biology, I have been honing my skills as a science and technical writer for 15 years. I have written for research institutes, biotech companies, medical device manufacturers, and in vitro diagnostic companies.

I also have a working knowledge of labeling requirements (FDA 21 CFR 801) and quality regulation and standards (FDA 21 CFR 820; ISO 13485). I have supported document editing and preparation for Quality and Regulatory Affairs teams.

Other projects I have worked on:

• Migration of documents between electronic quality management systems (EQMS).
• Scientific manuscripts and poster abstracts.
• Slide decks on topics of diabetes and endocrinology for diverse audiences: med students, patient groups, symposia, and philanthropic organizations.
• Substantive editing and copy editing of 10+ textbooks including two medical textbooks.
• Online content and search engine optimization/search engine marketing.

A few companies I have worked at include:

• Grifols Diagnostic Solutions - An in vitro diagnostic company developing assays for testing the blood supply for viruses and pathogens. Its parent company, Grifols, is based in Spain. They isolate proteins and manufacture medications from blood plasma.
• St. Jude Medical (acquired by Abbott) - A manufacturer of cardiac re-synchronization therapy devices (pacemakers).
• Medtronic Diabetes - A maker of continuous glucose monitoring devices and insulin pumps.

Visit my the Resume & Work Experience page for additional details.